INFUSE® Bone Graft 7510050Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00613994239518), received between Dec 7, 2016 and Jan 28, 2022 — classified as 29 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (1 report).

8 other recalls cover devices cleared under the same FDA submission (P000058, P050053); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• InjuryJan 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO HAD L4-5 OLIF WITH POSTERIOR PERCUTANEOUS HARDWARE FIXATION FOR DEGENERATIVE DISC DISEASE, SPONDYLITIS. PRIOR HISTORY OF SMOKING BUT HAD QUIT 6-10 YEARS PRIOR TO SURGERY IT WAS REPORTED THAT THE PATIENT PRESENTS WITH A NON-UNION AT THIS LEVEL AFTER BEING MORE THAN A YEAR POST-PROCEDURE.  THIS PATIENT HAS GONE ON TO NON-UNION FOR NO APPARENT REASON, THE SURGEON IS ASKING IF THERE WAS A LOT ISSUE WITH THE INFUSE. DUE TO THE LENGTH OF TIME PASSING BETWEEN THE DATE OF IMPLANTATION AND THE DATE OF REPORT, IT CANNOT BE DETERMINED IF THERE WAS ANY ISSUE WITH THE INFUSE PREPARATION BUT NONE WAS NOTED.THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 13381877 ↗
• InjuryJan 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO HAD L4-5 OLIF WITH POSTERIOR PERCUTANEOUS HARDWARE FIXATION FOR DEGENERATIVE DISC DISEASE, SPONDYLITIS. PRIOR HISTORY OF SMOKING BUT HAD QUIT 6-10 YEARS PRIOR TO SURGERY IT WAS REPORTED THAT THE PATIENT PRESENTS WITH A NON-UNION AT THIS LEVEL AFTER BEING MORE THAN A YEAR POST-PROCEDURE.  THIS PATIENT HAS GONE ON TO NON-UNION FOR NO APPARENT REASON, THE SURGEON IS ASKING IF THERE WAS A LOT ISSUE WITH THE INFUSE. DUE TO THE LENGTH OF TIME PASSING BETWEEN THE DATE OF IMPLANTATION AND THE DATE OF REPORT, IT CANNOT BE DETERMINED IF THERE WAS ANY ISSUE WITH THE INFUSE PREPARATION BUT NONE WAS NOTED.THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 13381818 ↗
• InjurySep 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE INFORMATION WAS RECEIVED FROM HEALTH CARE PROVIDER VIA A MANUFACTURING REPRESENTATIVE REGARDING A PATIENT FOR ORAL MAXILLOFACIAL SURGERY. IT WAS REPORTED THAT SURGEON USED INFUSE FOR BONE GRAFT ON TOOTH 12 DID THE EXTRACTION AND BONE GRAFT AT SAME TIME. SURGEON USED ONE X-SMALL INFUSE AND MINEROSS TOGETHER WHICH IS THE GO TO COMBINATION. AT TWO WEEK FOLLOW UP, ALL WAS FINE FOUR MONTHS LATER THE SITE WAS FULL OF PUSS AND INFECTED. PUSS OOZED WITH THE TOUCH. THE UPDATED CAT SCAN SHOWS THE DEFECT IS MUCH LARGER THAN IT WAS. THERE WAS NO FURTHER INFORMATION RECEIVED. ADDITIONAL INFORMATION RECEIVED STATES THAT PATIENT HAD PAST SURGICAL HISTORY, PAST HISTORY, CONCURRENT CONDITIONS, PAST DRUGS, AS O PROSTATE CANCER O CONTROLLED/HBP O ARTIFICIAL JOINT  LEFT HIP, 2 ELBOWS O DISTAL TRICEPS TENDON REPAIR ON (B)(6) 2021 O ALLERGIES: PENICILLIN CONCOMITANT MEDICATION: MEDICATIONS: 20MG QD LISINOPRIL AND BABY ASPIRIN. INITIAL PROBLEM: (B)(6) 2020  TOOTH WAS FRACTURED AND REMOVED IMPLANT PLACED - (B)(6) 2021 IMPLANT REMOVED ON (B)(6) 2021 AS IMPLANT WAS FAILING AND BONE GRAFTING WITH INFUSE DONE ON THIS DATE. ON (B)(6) 2021 THE PATIENT HAD AN IMPLANT PLACED FROM THE TOOTH (#12) EXTRACTION,

  Patient problems: Inflammation; Pain; Purulent Discharge

  MAUDE report 12493986 ↗
• InjuryMar 24, 2021Osseointegration Problem; Osseointegration Problem

  THE INFORMATION WAS RECEIVED FROM CONSUMER VIA MANUFACTURING REPRESENTATIVE REGARDING A PATIENT WITH INFUSE PART FOR SPINAL THERAPY. IT WAS REPORTED THAT INFUSE BONE LOSS IN THE BOTTOM FRONT OF JAW. TRIED ROUTE CANAL (FAILED) HAD TWO TEETH PULLED AND ADDED INFUSE TO THE AREA WHERE THE BONE LOSS WAS SO THEY COULD ADD TWO TOOTH IMPLANTS. THE PATIENT WAS TOLD THE INFUSE DID NOT GROW THE BONE AS ASSUMED AND NOW THEY WANT TO PULL TWO MORE TEETH AND TRY AGAIN. THERE WAS NO FURTHER COMPLICATION REPORTED. ADDITIONAL INFORMATION STATES THAT PRE-OP DIAGNOSIS-BONE LOSS IN JAW. PROCEDURE INVOLVED- BONE GRAFTING TO REBUILD JAW ¿ PREPARATION FOR DENTAL IMPLANTS. THE PATIENT REPORTED THAT THIS PRODUCT WAS USED IN THE PATIENT MOUTH/JAW, THE PATIENT¿S BONE DID NOT GROW ENOUGH BONE IN THE JAW FOR IMPLANTS AND WILL NEED TO HAVE ADDITIONAL SURGERY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 11559116 ↗
• InjuryNov 1, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS PRESENTED WITH FOLLOWING PRE-OP DIAGNOSIS: BILATERAL LUMBAR RADICULOPATHY, DEGENERATIVE SPONDYLOLISTHESIS, L4-L5, SPINAL STENOSIS, L3-L5, BILATERAL FORAMINAL STENOSIS, L3-L5, DEGENERATIVE DISK DISEASE, L3-S 1, STATUS POST LAMINECTOMY, L4-L5 WITH RIGHT DISKECTOMY, STATUS POST POSTOPERATIVE INFECTION, L4-L5, OBESITY. SHE UNDERWENT FOLLOWING PROCEDURES: REDO BILATERAL LAMINECTOMIES, L4-L5 WITH FORAMINOTOMIES, PARTIAL LAMINECTOMY, L3-L4 WITH BILATERAL FORAMINOTOMIES, NEUROLYSIS, RIGHT L4 NERVE ROOT, POSTERIOR LUMBAR INTERBODY FUSION, L4-L5, INSERTION OF TRICORTICAL ALLOGRAFT PROSTHESES, RIGHT L4-L5, POSTEROLATERAL FUSION, L4-L5, INSERTION OF EXTRA, EXTRA SMALL BONE GRAFT, INSERTION OF ALLOGRAFT CANCELLOUS BONE CHIPS, INSERTION OF AUTOGRAFT BONE FROM THE DECOMPRESSION, INSERTION OF SEQUOIA SPINAL INSTRUMENTATION AT L4-L5, PARTIAL REDUCTION OF SPONDYLOLISTHESIS AT L4-L5. AS PER THE OP-NOTES, ¿I DID FORAMINOTOMIES OF THE ADJACENT NERVE ROOTS AND I DECOMPRESSED THE LATERAL RECESSES PROXIMAL TO THIS. AT LEFT L4-L5, I DID FIND A MODERATE SIZED FACET CYST. IT DID APPEAR TO HAVE SYNOVIAL FLUID IN IT. ON THE MRI FROM FALL OF 2009, I DID NOT SEE ANY FLUID IN A LEFT L4-L5 FACET CY

  Patient problems: Adhesion(s); Ambulation or Postural Difficulties; Bone Fracture(s)

  MAUDE report 8029308 ↗
• InjuryJul 4, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH L4-L5 PSEUDOARTHROSIS WITH RETAINED HARDWARE, DEGENERATIVE DISC DISEASE, SEGMENTAL LUMBAR INSTABILITY AND SPINAL STENOSIS AND UNDERWENT THE FOLLOWING PROCEDURES: L4-L5 FUSION EXPLORATION. L4-5 REMOVAL POSTERIOR SEGMENTAL INSTRUMENTATION. L4 REVISION LAMINECTOMY WITH DECOMPRESSION OF CAUDA EQUINA AND SPINAL NERVE ROOTS. L5 LAMINECTOMY WITH DECOMPRESSION OF CAUDA EQUINA AND SPINAL NERVE ROOTS. L4-L5 REVISION POSTERIOR SPINAL FUSION. L4-L5 SEGMENTAL INSTRUMENTATION WITH PEDICLE SCREWS. USE OF LOCAL BONE GRAFT, CANCELLOUS ALLOGRAFT, AND BMP. INSERTION OF INDWELLING OPIOID CATHETER FOR POSTOP ANALGESIA. USE OF OPERATING MICROSCOPE. L4-L5 ANTERIOR LUMBAR DISKECTOMY AND INTERBODY FUSION. L4-L5 ANTERIOR LUMBAR MACHINE ALLOGRAFT. L4-5 ANTERIOR SEGMENTAL INSTRUMENTATION. AS PER OP-NOTES,¿ THE LEVEL WAS CONFIRMED USING A LATERAL IMAGE WITH THE SPINAL NEEDLE IN PLACE. THE L4- L5 ANNULOTOMIES CARRIED OUT AND A COMPLETE DISKECTOMY AND DECOMPRESSION FROM THE ANTERIOR ASPECT OF THE DISK SPACE WAS PERFORMED. THE PEEK INTERBODY DEVICE WAS REMOVED WITHOUT DIFFICULTY. THE PATIENT HAD BMP USED IN THE LAST SURGERY AND THERE WAS SOME INADVERTENT EXTRAVASATIO

  Patient problems: Injury

  MAUDE report 7662322 ↗
• InjuryMay 25, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT SUSTAINED UNSPECIFIED INJURIES FOLLOWING THE USE OF RHBMP-2/ACS IN AN UNSPECIFIED SPINAL FUSION SURGERY. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: Injury

  MAUDE report 7543891 ↗
• InjuryMay 9, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT FUSION SURGERY AT CERVICAL IN WHICH (B)(4) WAS USED.

  Patient problems: Injury

  MAUDE report 7500175 ↗
• InjuryMar 28, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT FUSION SURGERY IN WHICH RHBMP-2/ACS WAS USED.

  Patient problems: Injury

  MAUDE report 7376848 ↗
• InjuryNov 23, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT ALLEGEDLY SUSTAINED UNSPECIFIED INJURIES RESULTING FROM A SPINAL FUSION SURGERY USING RHBMP-2/ACS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Injury

  MAUDE report 7056742 ↗
• InjuryNov 20, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SPINAL FUSION SURGERY ON THE LUMBAR REGION OF HER SPINE FROM L4-S1. REPORTEDLY, RHBMP-2 WAS USED IN THIS SURGERY. REPORTEDLY, THE PATIENT'S POST-OPERATIVE PERIOD HAS BEEN MARKED BY INCREASINGLY SEVERE PAIN IN HER LEGS AND NERVE INJURY. IT WAS REPORTED THAT THE PATIENT CONTINUES TO EXPERIENCE RADIATING PAIN TO THE LEGS, NERVE INJURY, NUMBNESS IN BOTH LEGS, AND CONSTANT LOWER BACK PAIN. THIS PREVENTS HER FROM PRACTICING AND ENJOYING THE ACTIVITIES OF DAILY LIFE THAT SHE ENJOYED PRE-OPERATIVELY, AND SHE HAS OTHERWISE SUFFERED SERIOUS INJURIES. IT WAS REPORTED THAT ON (B)(6) 2008 THE PATIENT MRI OF THE LUMBAR SPINE WITH AND WITHOUT CONTRAST. IMPRESSION: UNILATERAL PARS INTRA-ARTICULARIS DEFECT ON THE LEFT AT L5 WITH MINIMAL GRADE I ANTERIOR SPONDYLOLISTHESIS L5 ON SL. LEFT POSTERIOR FOCAL DISC EXTRUSION AT L4-L5 AND RIGHT POSTERIOR. ON (B)(6) 2008 THE PATIENT PRESENTED WITH LOW BACK PAIN AND BILATERAL LEG PAIN. ON (B)(6) 2008: THE PATIENT ADMITTED TO HOSPITAL. THE PATIENT UNDERWENT X-RAY OF LUMBAR SPINE 2/3 VIEWS. THE PATIENT UNDERWENT THE SURGERY. PREOPERATIVE DIAGNOSIS: L4-L5 AND L5-S1 DEGENERATIVE DISC DISEASE WITH DISC HERNIATION AND L5-

  Patient problems: Ambulation or Postural Difficulties; Arachnoiditis, Spinal; Bronchitis; Chest Pain; Chronic Obstructive Pulmonary Disease (COPD); Depression; Dizziness; Edema; Fibrosis; Headache; High Blood Pressure/ Hypertension; Incontinence; Muscle Spasm(s); Nerve Damage; Nervous System Injury; Neuropathy; Numbness; Pain; Pneumonia; Pressure Sore/Ulcer; Scarring; Seroma; Stenosis; Swelling; Tingling; Weakness

  MAUDE report 7044365 ↗
• InjuryJul 10, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT DEMOGRAPHICS: (B)(6). IT WAS REPORTED PER PATIENT¿S MEDICAL RECORDS THAT ON: (B)(6) 2010 THE PATIENT UNDERWENT CERVICAL C5-6, CERVICAL C6-7 ANTERIOR CERVICAL DISCECTOMY AND FUSION. PREOPERATIVE DIAGNOSIS: DEGENERATIVE DISC DISEASE-CERVICAL, SPINAL STENOSIS-CERVICAL. THE PATIENT UNDERWENT FOLLOWING PROCEDURES: ANTERIOR CERVICAL DISCECTOMY AND FUSION C5-6 AND C6-7. ANTERIOR CERVICAL INSTRUMENTATION FROM C5-7. PLACEMENT OF ANTERIOR INTERBODY CAGES FROM C5-6 AND C6-7. PREOPERATIVE DIAGNOSIS: CERVICAL SPINAL STENOSIS C5-6, C6-7. AS PER OP NOTES: ¿THE CAGE WAS SIZED AND THE CAGE WAS PLACED AND PACKED WITH RHBMP-2, AUTOGRAFT AND ALLOGRAFT PLACED IN THE INTERBODY SPACE BETWEEN C5-6 AND C6-7. ANTERIOR PLATE WAS FASHIONED AND THEN SECURED TO THE BODY OF C5, C6 AND C7 USING LOCKING SCREWS.¿ ON (B)(6) 2010: PATIENT PRESENTED FOR AN OFFICE VISIT WITH DIAGNOSIS OF DEGENERATIVE DISK DISEASE. ASSESSMENT: PATIENT¿S MAIN IMPAIRMENTS ARE PAIN, STRENGTH AND JOINT HYPOMOBILITY DUE TO SPASMING. ON (B)(6) 2010 THE PATIENT WAS PRESENTED FOR OFFICE VISIT WITH NECK AND HEAD PAIN. THE PATIENT REPORTED INCREASING RIGHT SIDED NECK PAIN RADIATING UP TO HIS HEAD SEVERE. IMPRESSION: POST OPERATIVE NECK PA

  Patient problems: Disc Impingement; Injury; Pain

  MAUDE report 6699621 ↗
• InjuryJul 10, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON: (B)(6) 2010: THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH CERVICAL SPINAL STENOSIS C5-C6 AND CERVICAL DISK HERNIATION AT C5-C6. PATIENT UNDERWENT FOLLOWING PROCEDURES: ANTERIOR CERVICAL DISKECTOMY, C5-C6, ANTERIOR CERVICAL FUSION USING AUTO AND ALLOGRAFT, PLACEMENT OF ANTERIOR INTERBODY CAGE, PLACEMENT OF ANTERIOR CERVICAL INSTRUMENTATION. ALSO PATIENT COMPLAINED OF ACUTE PAIN AND INFECTION RISK, UNDERWENT MUSCOSKELETAL, NEURO EXAM. IMPRESSIONS: INTEROPERATIVE LATERAL VIEW SHOWS ANTERIOR FUSION AT C5-C6. PATIENT UNDERWENT SURGERY USING RHBMP-2/ACS. THE PATIENT UNDERWENT NEURO AND MUSCULOSKELETAL EXAM. ON (B)(6) 2010, (B)(6) 2011: THE PATIENT PRESENTED FOR FOLLOW UP VISIT AT THE HOSPITAL. ON (B)(6) 2010 (DATE IS APPROX.): THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH L3-L4, L4-L5 DEGENERATIVE DISK DISEASE AND L3-L4, L4-L5 DEGENERATIVE LUMBAR SPINAL STENOSIS AND UNDERWENT FOLLOWING PROCEDURES: L3-L4, L4-L5 DIRECT LUMBAR INTERBODY FUSION USING AUTO AND ALLOGRAFT, PLACEMENT OF LUMBAR INTERBODY CAGE L3-L4, L4-L5 USING AUTO AND ALLOGRAFT, POSTERIOR SPINAL INSTRUMENTATION L3-L4, L4-L5, POSTERIOR SPINAL FUSION USING AUTO AND ALLOGRAFT L3-L4, L4-L5, LUMBAR LAMINE

  Patient problems: Pain

  MAUDE report 6696364 ↗
• InjuryJul 10, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON: (B)(6) 2010: THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH CERVICAL SPINAL STENOSIS C5-C6 AND CERVICAL DISK HERNIATION AT C5-C6. PATIENT UNDERWENT FOLLOWING PROCEDURES : ANTERIOR CERVICAL DISKECTOMY, C5-C6; ANTERIOR CERVICAL FUSION USING AUTO AND ALLOGRAFT; PLACEMENT OF ANTERIOR INTERBODY CAGE; PLACEMENT OF ANTERIOR CERVICAL INSTRUMENTATION. ALSO PATIENT COMPLAINED OF ACUTE PAIN AND INFECTION RISK, UNDERWENT MUSCOSKELETAL, NEURO EXAM. IMPRESSIONS: INTEROPERATIVE LATERAL VIEW SHOWS ANTERIOR FUSION AT C5-C6. PATIENT UNDERWENT SURGERY USING RHBMP-2/ACS. THE PATIENT UNDERWENT NEURO AND MUSCULOSKELETAL EXAM. (B)(6). THE PATIENT PRESENTED FOR FOLLOW UP VISIT AT THE HOSPITAL. (B)(6) 2010 (DATE IS APPROX.): THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH L3-L4, L4-L5 DEGENERATIVE DISK DISEASE AND L3-L4, L4-L5 DEGENERATIVE LUMBAR SPINAL STENOSIS AND UNDERWENT FOLLOWING PROCEDURES: L3-L4, L4-L5 DIRECT LUMBAR INTERBODY FUSION USING AUTO AND ALLOGRAFT; PLACEMENT OF LUMBAR INTERBODY CAGE L3-L4, L4-L5 USING AUTO AND ALLOGRAFT; POSTERIOR SPINAL INSTRUMENTATION L3-L4, L4-L5; POSTERIOR SPINAL FUSION USING AUTO AND ALLOGRAFT L3-L4, L4-L5; LUMBAR LAMINECTOMY L4 ,L5; BILATERAL

  Patient problems: Pain

  MAUDE report 6696360 ↗
• InjuryJun 19, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2008, THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH SPONDYLOLISTHESIS AND STRUCTURAL INSTABILITY C3-4 CERVICAL SPINE. HERNIATED NUCLEUS PULPOSUS, SPINAL STENOSIS, DEGENERATIVE DISC AND JOINT DISEASE C3-4. SPINAL CORD COMPRESSION C3-4/MYELOPATHY AND UNDERWENT FOLLOWING PROCEDURES: ANTERIOR NEURAL DECOMPRESSION C3-4. ANTERIOR DISCECTOMY AND FUSION C3-4. ANTERIOR CAGE FIXATION C3-4. ANTERIOR PLATE FIXATION C3-4. INTRA-OPERATIVE BI-PLANE FLUOROSCOPY. AS PER OP-NOTES, ¿FLOSEAL AND GELFOAM PLACED OVER THE ANTERIOR CORD, AND THEN A 7.0 MM PEEK IMPLANT FILLED WITH CANCELLOUS AUTOLOGOUS BONE AND BONE MORPHOGENIC PROTEIN WAS PLACED INTO INTRADISCAL SPACE AT C3-4. THEN A PLATE WAS PLACED ON THE ANTERIOR BODY OF C3 AND C4 WITH TWO UNICORTICAL CANCELLOUS SCREWS PROXIMALLY AND DISTALLY AND LOCKED SECURELY.¿ POST OPERATIVELY PATIENT ALLEGES UNSPECIFIED INJURY DUE TO THE USE OF RHBMP-2.

  Patient problems: Injury

  MAUDE report 6649406 ↗
• InjuryMay 12, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON: (B)(6) 2012: THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH L2 COMPRESSION FRACTURE AND L1-L2 KYPHOLIC DEFORMITY AND POST-OPERATIVELY DIAGNOSED WITH L2 COMPRESSION FRACTURE AND L1-L2 KYPHOTIC DEFORMITY PLUS DEEP WOUND INFECTION AROUND PEDICLE SCREW HEADS. THE PATIENT UNDERWENT FOLLOWING PROCEDURES: REMOVAL OF PEDICLE SCREW INSTRUMENTATION AND REVISION INSTRUMENTATION. L2 PEDICLE SCREWS, LUMBAR AND PEDICLE SCREW INSTRUMENTATION OF L1 POSTERIOR SPINAL FUSION L1-L2 POSTERIOR INSTRUMENTATION L1-L4. IRRIGATION AND DEBRIDEMENT. DEEP LUMBAR WOUND. AS PER OP-NOTES, ¿ A HIGH SPEED BUR WAS USED TO DECORTICATE THE BILATERAL L1-L2 FACET JOINTS AND SMALL STRIPS OF RH-BMP2 WERE PLACED IN THE FACET JOINTS IN ORDER TO ACHIEVE A POSTERIOR FUSION.¿ POST-OP, THE PATIENT ALLEGED UNSPECIFIED INJURY DUE TO USE OF RHBMP-2.

  Patient problems: Injury

  MAUDE report 6562623 ↗
• InjuryApr 28, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON: (B)(6) 2012: PATIENT PRESENTED WITH FOLLOWING PRE-OP DIAGNOSIS: STATUS POST ANTERIOR CERVICAL DISCECTOMY AND FUSION C5-6, C6-7. 2. C5-6, C6-7 PAINFUL PSEUDOARTHROSIS. PAINFUL RETAINED HARDWARE IN C5-6, C6-C7. PATIENT UNDERWENT FOLLOWING PROCEDURES: REVISION OF C5-6 ANTERIOR CERVICAL DISCECTOMY AND FUSION WITH REMOVAL OF INTERVERTEBRAL BODY FUSION DEVICE. REVISION OF C6-7 ANTERIOR CERVICAL DISCECTOMY AND FUSION WITH REMOVAL ANTERIOR CERVICAL INTERVERTEBRAL BODY FUSION DEVICE. PLACEMENT OF C5-6 ANTERIOR CERVICAL INTERVERTEBRAL BODY FUSION DEVICE RHBMP-2/ACS. PLACEMENT OF C6-7 ALLOGRAFT ANTERIOR CERVICAL INTERVERTEBRAL BODY FUSION DEVICE WITH RHBMP-2/ACS. PLACEMENT OF C5-C7 ANTERIOR CERVICAL PLATE WHICH WAS RE-IMPLANTATION OF ANTERIOR HARDWARE. PER OPERATIVE -NOTES: ¿¿APPROPRIATE SIZE IMPLANT WAS OBTAINED, PACKED CENTRALLY WITH RHBMP-2/ACS SOAKED IN COLLAGEN SPONGE. IMPLANT WAS THEN TAMPED IN POSITION. GOOD ENDPLATE CONTACT, GOOD FORAMINAL DISTRACTION. THE CASPAR DISTRACTOR WAS RELEASED AND REMOVED. APPROPRIATE SIZE ANTERIOR CERVICAL PLATE WAS OBTAINED, WAS AFFIXED TO THE ANTERIOR CERVICAL SPINE. A 15 MM LONG SCREWS AT EACH LEVEL TWO AT C5, TWO AT C6, AND TWO

  Patient problems: Injury

  MAUDE report 6528798 ↗
• InjuryMar 10, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2012, PATIENT WAS PRE ¿OPERATIVELY DIAGNOSED WITH FACET ARTHROPATHY AND UNDERWENT THE FOLLOWING PROCEDURES: LEFT L4-L5 MINIMALLY INVASIVE TRANSFORAMINAL LUMBAR INTERBODY FUSION WITH LEFT TRANSPEDICULAR TOTAL FACETECTOMY APPROACH TO THE NERVE ROOT , INTERBODY ARTHRODESIS, BIOCHEMICAL SPACER , HARVEST OF BONE MARROW ASPIRATE ,HARVEST OF LOCAL AUTOGRAFT, POSTEROLATERAL ARTHRODESIS, ONE-LEVEL NON-SEGMENTAL PEDICLE SCREW INSTRUMENTATION AND USE OF OPERATING MICROSCOPE. AS PER-OP NOTES ¿FLUOROSCOPIC CONFIRMATION OF THE DISKECTOMY WAS CONFIRMED WITH THE SPINEOLOGY BALLOON AND THEN AN EXTRA SMALL BONE MORPHOGENIC PROTEIN WAS PLACED INTO THE ANTERIOR RECESSES OF THE DISK SPACE FOLLOWED BY ALL AUTOGRAFT MORSELIZED CHIPS FOLLOWED BY THE REMAINING VITOSS MIXED WITH BONE MARROW ASPIRATE AND THEN A 20 MM SPINEOLOGY WAS PREPARED ON THE BACK TABLE, SOAKED IN BONE MARROW ASPIRATE.¿ NO PATIENT COMPLICATIONS WERE REPORTED. PATIENT ALLEGES UNSPECIFIED INJURY DUE TO THE USE OF RHBMP-2.

  Patient problems: Injury

  MAUDE report 6394433 ↗
• InjuryFeb 24, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2009, PATIENT PRESENTED WITH FOLLOWING PRE-OP DIAGNOSES: SPONDYLOLISTHESIS. LUMBAR RADICULOPATHY. FOR WHICH, PATIENT UNDERWENT FOLLOWING PROCEDURE: TRANSFORAMINAL EPIDURAL STEROID INJECTION AT L4-5 AND L5-S1 ON THE LEFT UNDER FLUOROSCOPIC GUIDANCE. PATIENT TOLERATED THE PROCEDURE WELL WITHOUT ANY INTRAOPERATIVE COMPLICATIONS. ON (B)(6) 2009, PATIENT PRESENTED WITH FOLLOWING PRE-OP DIAGNOSES, SPONDYLOLISTHESIS. DEGENERATIVE DISK DISEASE. LUMBAR RADICULOPATHY. SPINAL STENOSIS. FOR WHICH, PATIENT UNDERWENT FOLLOWING PROCEDURE, TRANSFORAMINAL EPIDURAL STEROID INJECTION AT L4-5 AND S1 ON THE LEFT UNDER FLUOROSCOPIC GUIDANCE. PATIENT TOLERATED THE PROCEDURE WELL WITHOUT ANY INTRAOPERATIVE COMPLICATIONS. ON (B)(6) 2009, PATIENT PRESENTED WITH FOLLOWING PRE-OP DIAGNOSES, GRADE 2 L5-S1 SPONDYLOLISTHESIS. BILATERAL L5 FORAMINAL STENOSIS. FOR WHICH, PATIENT UNDERWENT FOLLOWING PROCEDURES, L5-S1 POSTERIOR LUMBAR INTERBODY FUSION WITH 11MM LUMINARY SPACERS AND AUTOGRAFT. L5-S1 DECOMPRESSIVE LAMINECTOMY WITH BILATERAL L5 FORAMINOTOMY. INSTRUMENTATION AT L5 AND S1 WITH PEDICLE SCREWS. POSTEROLATERAL FUSION AT L5 AND S1 WITH AUTOGRAFT AND BMP-2. PER OP NOTES, TRANSVE

  Patient problems: Injury

  MAUDE report 6355932 ↗
• InjuryFeb 24, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2012, THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH HERNIATED INTERVERTEBRAL DISC, C6-C7 AND UNDERWENT ANTERIOR CERVICAL DISCECTOMY AND INTERBODY FUSION, C6-C7. AS PER OP-NOTES, ¿AT THIS TIME, THE INTERBODY SPACE WAS PREPARED FOR PLACEMENT OF A 5 X 11 X 14 MM PEEK CAGE INTO WHICH ONE THIRD OF A PLEDGET OF BMP WAS PLACED. THIS WAS COUNTERSUNK APPROXIMATELY 3 TO 4 MM.¿ PATIENT ALLEGES UNSPECIFIED INJURY DUE TO THE USE OF RHBMP-2.

  Patient problems: Injury

  MAUDE report 6355919 ↗
• InjuryFeb 24, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT A FUSION SURGERY USING RH-BMP2. PATIENT ALLEGES UNSPECIFIED INJURY DUE TO THE USE OF RHBMP-2.

  Patient problems: Injury

  MAUDE report 6355918 ↗
• InjuryFeb 24, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON: (B)(6) 2008: THE PATIENT UNDERWENT ANTERIOR CERVICAL DISC FUSION AT C6-C7 USING RHBMP-2/ACS. ON AN UNKNOWN DATE POST-OP, PATIENT ALLEGED UNSPECIFIED INJURIES DUE TO USE OF RHBMP-2/ACS.

  Patient problems: Injury

  MAUDE report 6355631 ↗
• InjuryFeb 3, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON, (B)(6) 2011, THE PATIENT PRESENTED WITH A PRE-OP DIAGNOSIS OF RIGHT C7 AND LEFT C8 RADICULOPATHY BY ELECTRO MYOGRAPHY¿S (EMG¿S), FORAMINAL STENOSIS C6-C7, C7-T1 AND UNDERWENT THE ANTERIOR CERVICAL DISCECTOMY AND FUSION WITH BILATERAL FORAMINOTOMIES C6-C7, C7-T1. AS PER OP-NOTES, ¿WE SELECTED A LORDOTIC CORTICAL INTERBODY SPACER AND PACKED IT WITH A HALF A SPONGE OF AN EXTRA SMALL BONE MORPHOGENIC PROTEIN. THESE WERE 7 MM IN HEIGHT. THESE WERE IMPACTED INTO PLACE AND SATISFACTORY COUNTERSUNK.¿ PATIENT ALLEGES UNSPECIFIED INJURY DUE TO THE USE OF RHBMP-2.

  Patient problems: Injury

  MAUDE report 6299102 ↗
• InjuryFeb 3, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2008, PATIENT PRESENTED WITH PRE-OP DIAGNOSIS, CERVICAL RADICULOPATHY AND UNDERWENT FOLLOWING PROCEDURES: C5-6 AND C6-7 ANTERIOR CERVICAL DISKECTOMIES. UTILIZATION OF 2 SEPARATE BIOMECHANICAL DEVICES FOR ARTHRODESIS BETWEEN C5-6 AND C6-7. INTERBODY DEVICES, ANATOMICAL PEEK CAGES FILLED WITH RHBMP-2/ACS. ANTERIOR CERVICAL INSTRUMENTATION UTILIZING A ANTERIOR CERVICAL PLATE WITH SCREWS AT C5, C6 AND C7. CONTINUOUS NEUROPHYSIOLOGIC MONITORING. PER OP-NOTES, "THE WOUND WAS THEN IRRIGATED WITH COPIOUS AMOUNTS OF ANTIBIOTIC-IMPREGNATED SALINE, AND A 6 MM TRIAL WAS INSERTED IN EACH DISK SPACE AND NOTED TO BE OF ADEQUATE SIZE. A RASP WAS THEN PASSED INTO EACH DISK SPACE TO PREPARE THE ENDPLATES, AND THEN 2 SEPARATE 6MM X 14MM ANATOMICAL PEEK CAGES WERE FILLED WITH ONE-QUARTER OF RHBMP-2/ACS. EACH OF THESE INTERBODY DEVICES WAS TAPPED INTO PLACE UNDER DIRECT FLUOROSCOPY, CONFIRMING ADEQUATE PLACEMENT AND GOOD CERVICAL LORDOSIS. AN APPROPRIATELY SIZED PLATE WAS THEN PLACE ATOP THE VERTEBRAL BODIES AFTER SHAVING SOME OF THE REMAINING OSTEOPHYTES FROM C5-6. THIS WAS SECURED IN PLACE WITH A TEMPORARY PIN, AND THEN A HAND DRILL WAS USED TO DRILL 4 SEPARATE PILOT HO

  Patient problems: Injury

  MAUDE report 6299100 ↗
• InjuryDec 21, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2009, THE PATIENT PRESENTED WITH CERVICAL SPONDYLOSIS WITH MYELOPATHY AND STENOSIS. THE PATIENT UNDERWENT ANTERIOR CERVICAL DISKECTOMY, C4-5, ARTHRODESIS, C4-5 WITH POLYETHERETHERKETONE ALLOGRAFT, SUPPLEMENTATION OF ARTHRODESIS C4-5 WITH BONE MORPHOGENETIC PROTEIN SPONGE IMPLANT INSIDE ALLOGRAFT, SUPPLEMENTATION OF ARTHRODESIS C4-5 WITH CERVICAL PLATE AND USE OF THE MICROSCOPE AND MICRODISSECTION TECHNIQUE. AS PER OP NOTES, ¿¿..THE HIGH-SPEED DRILL WAS USED TO CONTOUR THE ENDPLATE SURFACES ON THE VERTEBRAL BODY OF C4 AND C5 IN A PARALLEL CONFIGURATION. THE ALLOGRAFT TRIAL SYSTEM WAS THEN USED AND 6-MM GRAFT WAS SELECTED AND APPROPRIATE PEEK LORDOTIC 6-MM IMPLANT WAS SELECTED. THE ACTUAL PEEK IMPLANT WAS FILLED WITH BONE MORPHOGENETIC PROTEIN DELIVERY SPONGE WITH A TOTAL DOSE OF 0.4 MG. THE SPONGE WAS PLACED INSIDE THE GRAFT AND THE GRAFT WAS TAPPED INTO PLACE WITH DIGITAL MANUAL DISTRACTION FROM THE HEAD OF THE TABLE. THE GRAFT WAS COUNTERSUNK A FEW MILLIMETERS. THE GRAFT HAD A VERY SATISFACTORY FIT AND CONTOUR. ALL THE INTERNAL AND EXTERNAL DISTRACTION WAS REMOVED AT THIS POINT.¿ PATIENT ALLEGES UNSPECIFIED INJURY DUE TO THE USE OF RHBMP-2.

  Patient problems: Injury

  MAUDE report 6192256 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P000058, P050053. One submission often covers many models, so check the product and lot details in each record.

• Z-0440-2019 · Sep 27, 2018 · Terminated
  INFUSE Bone Graft X SMALL KIT REF 7510100
• Z-1594-2013 · May 28, 2013 · Terminated
  INFUSE(R) Bone Graft, MEDIUM KIT, REF 7510400AUS, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopaedic
• Z-1592-2013 · May 28, 2013 · Terminated
  INFUSE(R) Bone Graft,LARGE II KIT, REF 7510800, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopaedic
• Z-1595-2013 · May 28, 2013 · Terminated
  INFUSE(R) Bone Graft, LARGE II KIT, REF 7510800AUS, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopaedic
• Z-1589-2013 · May 28, 2013 · Terminated
  INFUSE(R) Bone Graft, SMALL KIT, REF 7510200, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopaedic
• Z-1591-2013 · May 28, 2013 · Terminated
  INFUSE(R) Bone Graft, LARGE KIT, REF 7510600, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopaedic
• Z-1590-2013 · May 28, 2013 · Terminated
  INFUSE(R) Bone Graft, MEDIUM KIT, REF 7510400, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopaedic
• Z-1593-2013 · May 28, 2013 · Terminated
  INFUSE(R) Bone Graft, SMALL KIT, REF 7510200AUS, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopaedic