INFUSE® Bone Graft 7510200Recalls & reported problems

Summary

The FDA's MAUDE database contains 143 adverse event reports that list this exact device (DI 00681490843782), received between Nov 16, 2016 and Oct 9, 2023 — classified as 143 injuries.

The most frequently reported specific device problem is “Failure to Osseointegrate” (1 report).

8 other recalls cover devices cleared under the same FDA submission (P000058); 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 143 reports, in the reporter's own words as published by the FDA.

• InjuryOct 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A (REGULATORY BODY, PATIENT, HEALTH CARE PROFESSIONAL) VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH INFUSE AND CAGE. IT WAS REPORTED THAT PATIENT HAD SPINAL SURGERY TO IMPLANT A SPACER ON 2023 TO RELIEVE PRESSURE BETWEEN L3-4. TWO DEVICES WERE IMPLANTED IN SPINE LUMBAR. POST OP, BACTERIAL INFECTION WAS DIAGNOSED UPON ADMISSION TO HOSPITAL. PATIENT HAD EXPERIENCED SEVERE PAIN AND SPASMS SINCE SURGERY AND MRI WAS CONDUCTED AND FOUND THAT THERE WAS STATUS POST INTERBODY SPACER AT L3-4 WITH EDEMA IN THE DISC SPACE, ADJACENT VERTEBRAL BODIES, VENTRAL EPIDURAL SPACE AND PSOAS MUSCLE WITH APPARENT LEFT PSOAS ABSCESS. IT WAS ALSO FOUND THAT FINDINGS ARE CONCERNING FOR DISCITIS OSTEOMYELITIS. PATIENT HAD BEEN HOSPITALIZED AND TREATED WITH BROAD SPECTRUM IV ANTIBIOTICS AND RELEASED WITH PICC LINE INSTALLED TO CONTINUE IV ANTIBIOTICS FOR 6-8 WEEKS. DUE TO LAB ERROR, THE BACTERIA WAS NOT SPECIATED AND THERE WAS NO ORIGINAL SPECIMEN LEFT TO DO SO FROM BEFORE ANTIBIOTICS WERE ADMINISTERED IN THE HOSPITAL. EVENT STATED AS LIFE THREATENING AND REQUIRE INTERVENTION. THERE WERE NO FURTHER COMPLICATIONS THAT WERE REPORTED. ADDITIONAL INFORMA

  Patient problems: Abscess; Bacterial Infection; Cramp(s) /Muscle Spasm(s); Intervertebral Disc Compression or Protrusion; Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 17894039 ↗
• InjuryAug 24, 2020Failure to Osseointegrate; Failure to Osseointegrate

  INFORMATION WAS RECEIVED FROM A HEALTH CARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT FOR SPINAL THERAPY. IT WAS REPORTED THAT THE BMP DID NOT GROW ANY BONE AT ALL MULTIPLE FAILURE IN 2 SITES. HE SAYS HE HAS NEVER HAD THIS PROBLEM BEFORE, HE USES BMP AT LEAST 3 TIMES A MONTH. THE SURGEON ALSO WANTED TO KNOWN IF THE BMP DOESN'T WORK WITH THE MEDICINES THE PATIENT IS TAKING. 2020-AUGUST-12, E2,(REP): ADDITIONAL INFORMATION RECEIVED STATES THAT THE PATIENT IS SUFFERING FROM ACUTE AND CHRONIC SINUSITIS, J01.00, J32.0, AS WELL AS BONE GRAFT INFECTION, T86.832, FOREIGN BODY, REACTION, T18.0XXA, AND INFECTION FROM INTERNAL FIXATION DEVICES, T84.69XA. THE PATIENT HAD BOTH CALDWELL LUC AS WELL AS VERTICAL SINUSOTOMIES, CPT 31030, 31020. SURGEON ALSO REMOVED THE FAILED IMPLANTS, CPT 20680, AND PERFORMED BONE GRAFTS, BILATERALLY, CPT 21210 AFTER DEBRIDEMENT, CPT 11012. THE INFUSE WAS IMPLANTED INTO THE PATIENT'S MAXILLA AND INTO THE LATERAL SINUS WALLS, BILATERALLY. THERE WAS NO POSTOPERATIVE SYMPTOMS FROM THE PROCEDURE AND NO TISSUE EDEMA OR FLUID RETENTION. THE GRAFTS DID NOT SUCCEED. THE PROGRESS OF THE CASE HAS BEEN COPIED TO ALL OF THE PATIENT'S TREATING DOCTORS. THE

  Patient problems: Inadequate Osseointegration

  MAUDE report 10440873 ↗
• InjuryJan 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2009: THE PATIENT CAME FOR A FOLLOW-UP VISIT AND DIAGNOSED WITH(I) SPRAIN/STRAIN LUMBOSACRAL(JOINT)(LIGAMENT) (II) LOWER BACK PAIN (III) DEGENERATIVE LUMBAR DISC WITH ANGULAR TEAR L5-S1. ON (B)(6) 2009: THE PATIENT UNDERWENT MRI. IMPRESSIONS: DEGENERATIVE LUMBAR DISC WITH ANGULAR TEAR L5-S1. ON (B)(6) 2011: THE PATIENT WAS PRE-OPERATIVE DIAGNOSED WITH I) HERNIATED DISC L5-S1 II) INTERNAL DISC DISRUPTION III) LUMBAR INSTABILITY CAUSING PAIN IV) POSITIVE DISCOGRAM L5-S1 AND UNDERWENT L5-S1 ANTERIOR LUMBAR DISCECTOMY WITH INTERBODY FUSION USING PEEK CAGES AND BMP. AS PER OP NOTES, ¿I MADE AN INCISION IN THE ANTERIOR LONGITUDINAL LIGAMENT ANTERIOR ANNULUS AND REMOVED DISC MATERIAL IN BLOC FROM THE DISC INTERSPACE. I CONTINUED THE DISCECTOMY BACK TO THE POSTERIOR LONGITUDINAL LIGAMENT REMOVING MOST OF THE DISC IN THE INTERSPACE. AFTER THIS WAS COMPLETED I THEN CONFIRMED THAT WE HAD GONE POSTERIORLY TO THE APPROPRIATE DEPTH AND PUT IN A 16 MM DUAL TUBE DRILL GUIDE. THIS DRILL GUIDE AND REAMED WERE USED TO REMOVE THE ENDPLATE TO PUT IN THE TWO 16 MM CAGES ON EITHER SIDE OF MIDLINE. AFTER REAMING TO A DEPTH OF 29 MM I CONFIRMED THAT THIS WAS 3 MM FROM THE POSTERIOR EDGE OF THE AN

  Patient problems: Injury

  MAUDE report 9646319 ↗
• InjuryJan 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT OBLIQUE LUMBAR INTERBODY FUSION AT L4-L5. RHBMP-2/ACS WAS PLACED INSIDE THE CAGE AND WAS IMPLANTED AT L4-L5. THERE WERE NO INTRA-OP COMPLICATIONS. ONE YEAR POST-OP, THE PATIENT STILL DID NOT ACHIEVE FUSION.

  Patient problems: Failure of Implant

  MAUDE report 9553909 ↗
• InjuryAug 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON: (B)(6) 2014: THE PATIENT WAS PREOPERATIVELY DIAGNOSED WITH: SCOLIOSIS CORRECTION. THE PATIENT UNDERWENT THE FOLLOWING PROCEDURE: STAGE 2: T10 TO ILIUM DECOMPRESSION AND FUSION. L5 TO S1 TRANSFORAMINAL LUMBAR INTERBODY FUSION. AS PER OPERATIVE NOTES, ¿THE PATIENT WAS BROUGHT TO THE OPERATING THEATRE ON (B)(6) 2014. AND A #10 SCALPEL BLADE WAS THEN USED TO CUT THROUGH THE DERMIS. WE STARTED AT THE T10 LEVEL. UNDER FLUOROSCOPY GUIDANCE, WE THEN USED THE HIGH-SPEED MIDAS REX DRILL AND PLACED OUR PEDICLE SCREW ENTRY POINTS AT T10. AFTER THAT PLACED THE PEDICLE SCREW UNDER FLUOROSCOPIC IMAGING. THIS WAS DONE ALL THE WAY DOWN TO THE S1 LEVEL. ON THE LEFT SIDE AT THE L1 LEVEL, WE WERE NOT ABLE TO PLACE A PEDICLE SCREW BECAUSE OF A BRIDGE MEDIALLY. IN ADDITION, WE WERE NOT ABLE TO PLACE ONE AT L5 BECAUSE OF A BRIDGE AS WELL. AFTER PLACING SCREW THEN FOCUSED OUR ATTENTION ON UNDERTAKING THE TRANSFORAMINAL LUMBAR INTERBODY AT THE L5-S1. WE FOUND THAT THE L5 NERVE ROOT WAS QUITE LARGE AND EXITED QUITE LOW BELOW THE PEDICLE OF L5. THEN DECIDED TO PLACE THE SPACER ON THE LEFT SIDE. USING THE NERVE ROOT RETRACTOR, WE THEN RETRACTED THE NERVE ROOT. AFTER THAT WE USED DIFFE

  Patient problems: Failure of Implant; Pain

  MAUDE report 8933784 ↗
• InjuryAug 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT SPINAL SURGERY FROM L2-S1 DUE TO STENOSIS WITH DOCUMENTED PRE-OPERATIVE INSTABILITY. POST-OP, THE PATIENT HAD POSSIBLE LEFT L5 LLE RADICULOPATHY.

  Patient problems: Blood Loss; Neuropathy

  MAUDE report 8849458 ↗
• InjuryJul 28, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PER PATIENT'S MEDICAL RECORDS THAT ON: (B)(6) 2017: PATIENT CAME FOR FOLLOW UP. RADIOLOGY: MRI LUMBAR SPINE REVIEWED BY ME DEMONSTRATING SYNOVIAL CYST FORMATION L3-4 WITH SIGNIFICANT FACET ARTHROPATHY L3-4 AS WELL AS STENOSIS AT L5-S1 AND STENOSIS AT L2-3 CT SCAN LUMBAR SPINE SHOWS GOOD INTACT INSTRUMENTATION WITH EVIDENCE OF FACET ARTHROPATHY L3-4 AS WELL AS CORONAL DEFORMITY AND LOSS OF NORMAL LORDOSIS WITH AN APEX AT L3. THE PATIENT PRESENTED WITH THE FOLLOWING PRE-OP DIAGNOSIS: JUNCTIONAL STENOSIS IN THE LUMBAR SPINE. LUMBAR DEGENERATIVE SCOLIOSIS. SYNOVIAL CYST. THE PATIENT UNDERWENT FOLLOWING PROCEDURES: DIRECT LATERAL INTERBODY FUSION AT L2-L3, L3-L4 WITH PEEK INTERBODY ALLOGRAFT AND NEURO MONITORING POSTERIOR REVISION WITH REINSERTION OF LUMBAR INSTRUMENTATION, L3-L4 LAMINECTOMY FOR RESECTION OF SYNOVIAL CYST, L2-PELVIS FUSION WITH AUTOGRAFT, POSTERIOR INSTRUMENTATION AND NEURO MONITORING WITH O-ARM/STEALTH APPROACH. AS PER OPERATIVE NOTES, ¿I PREPARED THE ENDPLATES APPROPRIATELY, WITH ASSISTANCE FROM THE MID-LEVEL PROVIDER PROVIDING SOFT TISSUE RETRACTION AND NEURAL STRUCTURE RETRACTION AS NEEDED. I ALSO PERFORMED A CONTRALATERAL RELEASE. I THEN PLACED VARI

  Patient problems: Injury; Pain; Stenosis

  MAUDE report 8834610 ↗
• InjuryJul 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PER PATIENT MEDICAL RECORDS THAT ON: (B)(6) 2007: THE PATIENT PRESENTED WITH THE FOLLOWING PRE-OPERATIVE DIAGNOSIS: CERVICAL DEGENERATION. THE PATIENT UNDERWENT THE FOLLOWING PROCEDURES: C6-C7 DISKECTOMY. C6-C7 INTERBODY FUSION. INTERBODY IMPLANT. ANTERIOR PLATING. AS PER OPERATIVE NOTES, ¿A 7 MM LORDOTIC SPACER WAS SELECTED. BMP-2 MEASURING ONE-HALF OF A STRIP WAS PLACED. THE PLATE WAS PLACED WITH 13 MM SCREWS. CROSSTABLE LATERAL RADIOGRAPH WAS TAKEN TO CONFIRM PROPER GRAFT AND HARDWARE PLACEMENT.¿ ON (B)(6) 2007: THE PATIENT WAS DISCHARGED. ON (B)(6) 2019: THE PATIENT PRESENTED WITH THE FOLLOWING PRE-OPERATIVE DIAGNOSIS: C5-C6 ADJACENT SEGMENTAL DISEASE. THE PATIENT UNDERWENT THE FOLLOWING PROCEDURE: ANTERIOR CERVICAL DISCECTOMY AND FUSION C5-C6. IMPLANTS, MANUFACTURED BY OTHER MANUFACTURERS, WERE USED IN THIS SURGERY. AS PER OPERATIVE NOTES, ¿WE PLACED A MOSQUITO CLAMP ONTO THE DISC SPACE AND VERIFIED THE POSITION WITH LATERAL FLUOROSCOPY CONFIRMING THE OPERATIVE LEVEL C5-C6. A LARGE OSTEOPHYTE WHICH I REMOVED AND SENT TO PATHOLOGY. EXPLORED THE FUSION BENEATH THAT I DIDN¿T SEE ANY PLATE. IT APPEARS TO HAVE DISSOLVED OR CONVERTED TO BONE AND WAS A SOLID FUSION FR

  Patient problems: Pain

  MAUDE report 8827807 ↗
• InjuryMay 9, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT OBLIQUE LUMBAR INTERBODY FUSION AND POSTERIOR FUSION AT L4-L5 DUE TO SPONDYLOLISTHESIS. ON AN UNKNOWN DATE, POST-OP, PATIENT STARTED TO HAVE L5 NERVE ROOT PAIN THAT MAY BE INFLAMMATORY AT L4-L5. SURGEON ALSO REMARKED THAT THE PATIENT'S BACK PAIN WAS SEVERE, BUT THAT MAY BE FROM L2-L3. PATIENT RECEIVED AN EPIDURAL STEROID INJECTION ON (B)(6) 2019, AFTER WHICH THE PATIENT STATED WORSENING OF HIS SYMPTOMS.

  Patient problems: Inflammation; Pain

  MAUDE report 8596635 ↗
• InjuryMay 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT OBLIQUE LATERAL INTERBODY FUSION AND POSTERIOR FUSION SURGERY AT L2-3 DUE TO INTERVERTEBRAL DISC DEGENERATION AND LUMBAR LOW BACK PAIN. AT APPROXIMATELY 18 MONTHS POST-OP, PATIENT SYMPTOMATIC AND SHOWING SIGNS OF AN INFLAMMATORY RESPONSE (MUSCLE ACHES, WEAKNESS, JOINT PAIN, BACK PAIN, DIFFICULTY WALKING, WEAKNESS AND NUMBNESS, DEPRESSION AND ANXIETY). SURGEON DESCRIBES RESPONSE AS ¿OVER-EXUBERANT OSTEOCLAST ACTIVATION FROM BONE MORPHOGENETIC PROTEIN (BMP)¿. ADDITIONALLY, THERE HAVE BEEN NO REPORTS OF INDICATIONS OF ANY ACTIVE INFECTION FROM THE TIME OF IMPLANTATION. ON (B)(6) 2017: PATIENT UNDERWENT A POSTERIOR PEDICULAR BIOPSY AND REDO L2-3 LAMINECTOMY FOR RECURRENT STENOSIS AND A LYRIC LESION IN HIS VERTEBRA. RESULT: WOUND WAS NORMAL, CULTURES GREW NO ORGANISMS AND HAD NEGATIVE GRAM STAIN.

  Patient problems: Ambulation or Postural Difficulties; Anxiety; Depression; Pain; Stenosis; Weakness

  MAUDE report 8576888 ↗
• InjuryNov 6, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH L4-S2 PSEUDO ARTHROSIS WITH BROKEN SPINAL INSTRUMENTATION, INTRACTABLE BACK PAIN AND UNDERWENT THE FOLLOWING PROCEDURES: L4-L5 AND L5-S1 ANTERIOR LUMBAR INTERBODY FUSION. PLACEMENT OF PEEK CAGE SCREW CONSTRUCT L4-L5 AND L5-S1, ALLOGRAFT BONE MATRIX, BONE MORPHOGENIC PROTEIN. NEUROMONITORING. REMOVAL OF INSTRUMENTATION L4 THROUGH S1, REVISION SPINAL INSTRUMENTATION L4 TO THE ILIUM, REVISION POSTEROLATERAL FUSION, L4 TO ILIUM, LOCAL MORCELLIZED AUTOGRAFT, ALLOGRAFT BONE MATRIX, BONE MORPHOGENIC PROTEIN, NEUROMONITORING, INTRAOPERATIVE O-ARM CT SCAN WITH COMPUTER NAVIGATION, CONNECTION OF FUSION TO PRIOR T10-L4 INSTRUMENTATION. AS PER OP-NOTES,¿ THE SET SCREWS FROM L4 DOWN TO THE ILIUM WERE REMOVED. THE BROKEN ROD WAS REMOVED AND THEN THE REMAINING RODS WERE CUT UP ABOVE THE L4 LEVEL. THE LOOSE SCREWS AT L4 THROUGH S1 WERE REMOVED. O-ARM REGISTRATION WAS PLACED IN THE ILIAC CREST. O-ARM WAS BROUGHT IN FOR INTRAOPERATIVE CT SCAN. COMPUTER REGISTRATION MATERIALS VERIFIED. UNDER COMPUTER GUIDANCE, NEW SCREWS WERE PLACED FROM L4 DOWN TO THE ILIUM. O ARM BROUGHT BACK IN TO VERIFY GOOD PLACEMENT OF INSTRUMENTATION, RODS WER

  Patient problems: Pain

  MAUDE report 8040718 ↗
• InjuryJul 11, 2018Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT FUSION SURGERY IN WHICH RHBMP2/ACS WAS USED.

  Patient problems: Injury

  MAUDE report 7676986 ↗
• InjuryJun 29, 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 7651313 ↗
• InjuryJun 27, 2018Adverse 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 UNDERWENT ANTERIOR LUMBAR INTERBODY FUSION ON L3-S1. HE WAS IMPLANTED WITH RHBMP-2/ACS. POST-OP, THE PATIENT SUFFERED FROM PROGRESSIVELY WORSENING LOW BACK PAIN WITH RADICULOPATHY IN HIS LOWER EXTREMITIES. CURRENTLY, THE PATIENT CONTINUES TO EXPERIENCE CHRONIC LOW BACK PAIN, PAIN AND RADICULOPATHY IN HIS LOWER EXTREMITIES, AND SWELLING IN HIS KNEES. HE IS UNABLE TO SIT OR WALK FOR EXTENDED PERIOD OF TIME. THESE SERIOUS INJURIES PREVENT THE PATIENT FROM PRACTICING AND ENJOYING THE ACTIVITIES OF DAILY LIFE THAT HE ENJOYED PRE-OPERATIVELY, AND HE HAS OTHERWISE SUFFERED SERIOUS AND PERMANENT INJURIES. ALSO, IT WAS REPORTED THAT THE PATIENT PRESENTED WITH THE FOLLOWING PRE-OP DIAGNOSIS: L3-L4, L4-L5, AND L5-S1 LUMBAR DISK DISEASE. PSEUDOARTHROSIS AT L3-L4 WITH DISCOGENIC BACK PAIN AT L3-L4, L4-L5, AND L5-S1. THE PATIENT UNDERWENT THE FOLLOWING PROCEDURES: ANTERIOR EXPOSURE OF THE LUMBAR SPINE TO L3-L4, L4-L5, AND L5-S1 LUMBAR DISKS TO FACILITATE INTERBODY FUSION AT THESE LEVELS. ARTHRODESIS ANTERIOR INTERBODY TECHNIQUE AT L3-L4, L4-L5, AND L5-S1 WITH INSERTION OF ANTERIOR INTERBODY SPACERS. ANTERIOR FILLER INSTRUMENTATION PLACEMENT AT L

  Patient problems: Ambulation or Postural Difficulties; Neuropathy; Pain

  MAUDE report 7641425 ↗
• InjuryJun 27, 2018Adverse 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 PRESENTED WITH FOLLOWING PRE-OP DIAGNOSIS: CERVICAL PSEUDARTHROSIS AT C5-6 AND POSSIBLY C4-5. ALSO, FORAMINAL NARROWING BILATERALLY, WORSE ON THE RIGHT TO THE LEFT AT C5-6. PATIENT UNDERWENT FOLLOWING PROCEDURES: (1) POSTERIOR SPINAL FUSION C4-C5, C5-C6. (2) POSTERIOR SPINAL INSTRUMENTATION, SEGMENTAL, AT 4-5, C5-C6. (3) AUTOLOGOUS LOCAL BONE GRAFTING AUGMENTED WITH RHBMP2 AND VITOSS BONE GRAFT SUBSTITUTE. (4) POSTERIOR CERVICAL BILATERAL C5, C6 LAMINOTOMIES, FORAMINOTOMIES AND MEDIAL FACETECTOMIES. AS PER OPERATIVE NOTES,¿ THE POSTERIOR BONY ELEMENTS WERE DECORTICATED, AND THE AUTOLOGOUS LOCAL BONE WAS USED FOR FUSION. THE BLEEDING FROM THE BONE WAS USED TO SOAK THE VITOSS BONE GRAFT SUBSTITUTE. THEN, RHBMP2 SPONGE WAS PLACED AT THE AREA OF THE POSTERIOR ELEMENTS IN THE INTERSPINOUS SPACE, INTERLAMINAR SPACE, AND ALSO THE FACET JOINTS TO ENHANCE FACET FUSION. THEN, BONE GRAFT SUBSTITUTE WAS ADDED ON TOP OF THE AUTOLOGOUS BONE AND RHBMP2.¿ REPORTEDLY, THE PATIENT WAS DIAGNOSED WITH THE FOLLOWING POST-OPERATIVELY: CERVICAL SPONDYLOSIS AND STENOSIS BILATERALLY IN THE FORAMEN, WORSE ON THE RIGHT THAN THE LEFT AT CS-6 AND A SOLID FUSION

  Patient problems: Injury

  MAUDE report 7641147 ↗
• InjuryJun 17, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH THE FOLLOWING PRE-OP DIAGNOSIS: NECK PAIN AND RIGHT UPPER EXTREMITY PAIN DUE TO SPONDYLOSIS AT C5-C6. THE PATIENT UNDERWENT THE FOLLOWING PROCEDURES: ANTERIOR CERVICAL DISCECTOMY AND FUSION AT C5-C6 WITH PARTIAL CORPECTOMY WITH THE USE OF 10MM CAGE AND SMALL AMOUNT OF RHBMP-2/ACS AND 25MM PLATE AND FOUR 15MM SCREWS WITH INTRAOPERATIVE SINGLE-STRAND CONFORMATION POLYMORPHISM MONITORING ON MICROSCOPE AND FLUOROSCOPY. AS PER OPERATIVE NOTES, ¿AT THIS POINT, THE WOUND WAS IRRIGATED WITH ANTIBIOTIC SOLUTION AND DISK SPACE WAS MEASURED AND BECAUSE OF THE OSTEOPHYTE THE SURGEON HAD TO DO A PARTIAL CORPECTOMY, A 10MM CAGE WITH SMALL AMOUNT OF RHBMP-2/ACS WAS PLACED IN AND CHECKED WITH FLUOROSCOPY AND KOSHERS AND THERE WAS NO MOVEMENT PRESENT AND IT WAS IN PERFECT POSITION.¿ NO INTRA-OPERATIVE COMPLICATIONS WERE REPORTED. ON (B)(6) 2009 THE PATIENT WAS DISCHARGED FROM THE FACILITY.

  Patient problems: Injury

  MAUDE report 7608488 ↗
• InjuryJun 13, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT FUSION SURGERY IN WHICH RHBMP2/ACS WAS USED.

  Patient problems: Injury

  MAUDE report 7595157 ↗
• InjuryJun 6, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH THE FOLLOWING PRE-OP DIAGNOSIS: L4-5 INTERBODY CAGE EXTRUSION. BACK PAIN. THE PATIENT UNDERWENT THE FOLLOWING PROCEDURES: REMOVAL OF L4-5 CAGE, AND PLACEMENT OF A LARGER CURVED PEEK NUVASIVE CAGE. REPAIR OF CEREBROSPINAL FLUID LEAK. INTERBODY FUSION USING BONE MORPHOGENIC PROTEIN. FLUOROSCOPIC GUIDANCE. AS PER OP-NOTES, ¿DISSECTION WAS THEN CARRIED OUT ON THE RIGHT SIDE AND THE CAGE WAS IDENTIFIED, THE CAGE WAS REMOVED, AND THE DISK SPACE WAS PREPARED. THE ANTERIOR DISK SPACE WAS THEN PACKED WITH BMP AND AUTOLOGOUS BONE. A 14-MM, 9-MM CURVED LORDOTIC CAGE WAS PLACED INTO THE L4-5 DISK SPACE AND COMPRESSED AGAINST THE L4-5 SCREWS.¿

  Patient problems: Injury

  MAUDE report 7572715 ↗
• 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 7543899 ↗
• InjuryMay 23, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH THE FOLLOWING PRE-OP DIAGNOSIS: CERVICAL STENOSIS C4-C5 AND C5-C6. THE PATIENT UNDERWENT THE FOLLOWING PROCEDURES: ANTERIOR CERVICAL DISKECTOMY AND FUSION WITH PLATING, C4-C5 AND C5-C6 USING RHBMP-2/ACS. NO INTRA-OPERATIVE COMPLICATIONS WERE REPORTED.

  Patient problems: Injury

  MAUDE report 7538293 ↗
• InjuryMay 15, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT ANTERIOR LUMBAR INTER-BODY FUSION AT L5-S1 IN WHICH RHBMP-2/ACS AND CAGE WAS USED ALONG WITH HER BONE FROM HER ILIAC CREST. POST-OPERATIVELY, PATIENT IS SUFFERING FROM SEVERE PAIN STARTING IN HER LOWER BACK, BUTTOCKS AND LEGS, MORE ON THE LEFT THAN ON THE RIGHT. PATIENT HAS NERVE ROOT EXPOSURE AT S1. PATIENT WAS DISCHARGED FROM THE HOSPITAL PRIOR TO HAVING A BOWEL MOVEMENT AND SO WAS IMPACTED. PATIENT HAD TO STRAIN AFTER GETTING HOME TO HAVE A BM, WHICH PATIENT FEELS CAUSED THE NERVE ROOT TO BE EXPOSED THUS CAUSING THIS ISSUE WITH THE PAIN. ALLEGEDLY, PATIENT IS UNABLE TO WORK OR DO EVERY DAY MOVEMENTS. PATIENT ONLY FINDS RELIEF BY TAKING PAIN PILLS AND MUSCLE RELAXERS. THE DOCTOR SAYS THAT SCAR TISSUE COULD BE THE CAUSE OF THE PROBLEM AND DISAGREES WITH PATIENT'S THEORY. AS A RESULT OF THIS EVENT, PATIENT UNDERWENT EMG WHICH SHOWED SOME S1 NERVE ROOT IRRITATION; HOWEVER, MRI WITH CONTRACT DID NOT SHOW ANYTHING.

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 7514148 ↗
• InjuryApr 27, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH FOLLOWING PRE-OP DIAGNOSIS: DISCOGENIC PAIN L3-L4, L4-5 AND L5-S1. HE UNDERWENT FOLLOWING PROCEDURES: A 360 DEGREE FUSION OF L4 THROUGH S1 AND ANTERIOR EXPOSURE. AS PER OPERATIVE NOTES, ¿THE SURGEON RASPED THE ENDPLATES UNTIL A POINT THAT I WAS CONVINCED THAT THERE WAS BLEEDING ENDPLATES. ANLT CAGE WITH BONE MORPHOGENIC PROTEIN WAS PLACED. FOR ANTERIOR INSTRUMENTATION SURGEON PLACED A 6.5 MM BUTTRESS SCREW WITH A WASHER.¿ NO INTRA-OPERATIVE COMPLICATIONS WERE REPORTED. POST-OPERATIVELY PATIENT COMPLAINED OF SUFFERING FROM SERIOUS PAIN AND LIMITED PHYSICAL MOBILITY.

  Patient problems: Injury; Pain

  MAUDE report 7468240 ↗
• InjuryApr 17, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT FUSION SURGERY IN WHICH RHBMP2/ACS WAS USED.

  Patient problems: Injury

  MAUDE report 7438161 ↗
• InjuryApr 13, 2018Adverse 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 FOLLOWING PRE-OP DIAGNOSIS: L3 LATERAL RECESS SPINAL STENOSIS, SECONDARY TO LIGAMENTUM FLAVUM HYPERTROPHY, FACET CAPSULAR HYPERTROPHY, NEUROFORAMINAL NARROWING SECONDARY TO DISK SPACE HEIGHT COLLAPSE AND BULGING. L4 LATERAL RECESS SPINAL STENOSIS, SECONDARY TO LIGAMENTUM FLAVUM HYPERTROPHY, FACET CAPSULAR HYPERTROPHY, NEUROFORAMINAL NARROWING SECONDARY TO DISK SPACE HEIGHT COLLAPSE AND BULGING. L3-4 PSEUDARTHROSIS. HISTORY OF L3-4 POSTERIOR DECOMPRESSION AND INSTRUMENTED POSTEROLATERAL FUSION IN 2009. L3-4 UNSTABLE SPONDYLOLISTHESIS. FAILURE OF POSTERIOR INSTRUMENTATION. LOWER EXTREMITY RADICULITIS. MECHANICAL BACK PAIN. SHE UNDERWENT THE FOLLOWING PROCEDURES: L3-4 ANTERIOR DISCECTOMY WITH DECOMPRESSION OF CAUDA EQUINE AND NERVE ROOTS. L3-4 VERTEBRAL INTERSPACE APPLICATION OF BONE GRAFT FILLED IN A LORDOTIC CAGE. L3-4 ARTHRODESIS, RETROPERITONEAL ANTERIOR INTERBODY TECHNIQUE WITH ALLOGRAFT AND BONE MORPHOGENIC PROTEIN PLACED WITHIN THE INTERBODY DEVICE. EXPLORATION OF FUSION. CONTINUOUS BILATERAL LOWER EXTREMITY EMG MONITORING. NAVIGATION FOR SPINE SURGERY. AS PER OPERATIVE NOTES, ¿PEEK CAGE CHOSEN FOR IMPLANTATION WA

  Patient problems: Injury

  MAUDE report 7428008 ↗
• InjuryApr 10, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2007, THE PATIENT WAS PRESENTED WITH THE FOLLOWING PRE-OP DIAGNOSIS: QUAD WITH RUPTURE INTERVERTEBRAL DISC C5-6 6-7. HE UNDERWENT FOLLOWING PROCEDURE: ANTERIOR CERVICAL CORPECTOMIES IN WHICH RHBMP-2 WAS USED. NO INTRA-OP COMPLICATIONS WERE REPORTED.

  Patient problems: Injury

  MAUDE report 7413597 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P000058. 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-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-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-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-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
• 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-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-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