INFUSE® Bone Graft 7510800Recalls & reported problems

Summary

The FDA's MAUDE database contains 180 adverse event reports that list this exact device (DI 00681490843829), received between Nov 16, 2016 and Sep 17, 2025 — classified as 180 injuries.

The most frequently reported specific device problem is “Fitting Problem” (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 180 reports, in the reporter's own words as published by the FDA.

• InjurySep 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION RECEIVED FROM CONSUMER VIA MANUFACTURER REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING POST-OP OF THE REPORTED IMPLANTS. IT WAS REPORTED THAT; PATIENT WAS ALLERGIC TO NICKEL AND EXPERIENCING SYMPTOMS. PROCEDURE/TECHNIQUE PERFORMED WAS TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) AT THE LEVELS L1-L3. INITIAL SURGERY WAS PERFORMED IN THE (B)(6) 2007. PATIENT HAD A REVISION SURGERY IN (B)(6) 2007. THE REVISION SURGERY WAS PERFORMED FOR RE-EXPLORATION OF THE L2 FRACTURE, T12-L3 FUSION EXTENSION, REPAIR OF TONGUE LACERATION, REVISION OF THE INSTRUMENTATION DUE TO HARDWARE LOOSENING. PATIENT HAS ALLERGY TO NICKEL WHICH HAS BEEN DEMONSTRATED BOTH BY SKIN PATCH TESTING AND A METAL-LTT BLOOD TEST WAS PERFORMED. THE PATIENT SUFFERS DUE TO HIS IMPLANT. IT WAS DISCOVERED THAT THERE WAS CORROSION AND BENDING OF RODS. IT WAS STATED THAT, IN 2022 PATIENT DEVELOPED METALLOSIS AND ADVERSE LOCAL TISSUE REACTIONS (ALTR) THROUGH HEAVY METAL URINE TESTS AND MRI IMAGING. PATIENT HAD SERIOUS SOFT TISSUE ISSUES THROUGHOUT HIS BODY AND LAST WEEK IT WAS TOLD THAT HE WILL NEED ALL THE TEETH REMOVED TO DAMAGE ATTRIBUTED TO HEAVY METAL POISONING AND HAVE SEVERE PERIODONTAL DISEASE ALONG WITH TE

  Patient problems: Anxiety; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Arrhythmia; Autoimmune Disorder; Inflammation; Neuropathy; Swelling/ Edema; Swollen Lymph Nodes/Glands

  MAUDE report 23074268 ↗
• InjuryJul 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION RECEIVED FROM HEALTHCARE PROVIDER VIA MANUFACTURER REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING POST-OP OF THE REPORTED PRODUCT. THE PRE-OP DIAGNOSIS WAS MENTIONED AS REVERSAL OF NORMAL CERVICAL LORDOSIS IS NOTED. NORMAL CORONAL ALIGNMENT. THERE IS VISUALIZATION BELOW C6. VERTEBRAL BODY HEIGHTS ARE PRESERVED. CONGENITAL STENOSIS IS NOTED. THERE IS SEVERE SUB-AXIAL CENTRAL STENOSIS MOST NOTABLE AT C4-5 AND C5-6 BUT TO A DEGREE C3-T1. FORAMINAL NARROWING NOTED THROUGHOUT AS WELL. IT WAS REPORTED THAT, PATIENT WAS FINE A WEEK AFTER POST OP. THE DOCTOR BELIEVES THE INFLAMMATION WAS CAUSED BY THE INFUSE WHICH LEAD TO THE RADICULITIS. THE REPORTED PRODUCT WAS USED ACCORDING TO IFU AND LABELLING. THE PRODUCT WAS IMPLANTED AT POSTERO-LATERAL AND LEVELS IMPLANTED WERE C2-T2. THE TYPE OF PROCEDURE PERFORMED PCF. THERE WAS AN ADDITIONAL TREATMENT OR INTERVENTION PERFORMED BUT MEDICATION/INTERVENTION PROVIDED TO THE PATIENT WAS UNKNOWN. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: Inflammation; Neuropathy

  MAUDE report 14975476 ↗
• InjuryFeb 19, 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 MANUFACTURE REPRESENTATIVE REGARDING INFUSE PART FOR SPINAL THERAPY. IT WAS REPORTED THAT PATIENT SUFFERED POSTOPERATIVE INFECTION FOLLOWING A SURGICAL PROCEDURE. THE SPECIFIC ORGANISM OF CONCERN IS MYCOBACTERIUM FORTUITUM. AT THE REQUEST OF THE DIVISION OF INFECTIOUS DISEASE, FACILITY CONTACTED MEDTRONIC DIRECTLY TO IDENTIFY IF THERE MAY BE A REASONABLE CHANCE THE INFUSE PART WOULD HAVE BEEN SUBJECT TO CONTAMINATION OR WHETHER THERE HAVE BEEN ANY REPORTED INCIDENCES OF INFECTION ASSOCIATED WITH ITS USE. ADDITIONAL INFORMATION RECEIVED STATES THAT ORIGINAL SURGICAL PROCEDURE DATE(B)(6) 2020 AND READMISSION DATE (B)(6) 2020 FOR SURGICAL INFECTION OF SURGICAL SITE. PRE-OP DIAGNOSIS: KYPHOSCOLIOSIS. PROCEDURE INVOLVED: LUMBAR 5- SACRAL 1 ANTERIOR LUMBAR INTERBODY FUSION, THORACIC 10-PELVIS POSTERIOR SPINAL FUSION INSTRUMENTATION WITH APICAL OSTEOTOMY AND LAMINECTOMY. NO COMPLICATIONS OTHER THAN THE SURGICAL SITE INFECTION AS REPORTED

  Patient problems: Bacterial Infection

  MAUDE report 11347398 ↗
• InjuryAug 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  18 MAR 2014: AS PER THE OP-NOTES, ¿#10 SCALPEL BLADE WAS THEN USED TO CUT THROUGH DERMIS. THE BOVIE MONOPOLAR CAUTERY WAS THEN USED TO CUT ALL THE WAY DOWN TO THE FASCIA OF THE EXTERNAL OBLIQUE. THE FASCIA OF THE EXTERNAL OBLIQUE WAS THEN CUT THROUGH WITH THE CAUTERY. THE EXTERNAL OBLIQUE WAS THEN DISSECTED THROUGH UNTIL THE FASCIA OF THE INTERNAL OBLIQUE WAS SEEN. THIS WAS ALSO DISSECTED THROUGH. WE THEN SAW THE FASCIA OF THE TRANSVERSUS RECTUS. WE THEN STIMULATED THIS WITH THE NIM PROBE TO MAKE SURE THERE WAS NO IMPORTANT NERVE PASSING THROUGH. WE FOUND AN AREA WHERE THERE WERE NO IMPORTANT STRUCTURES. THIS WAS THEN DISSECTED THROUGH WITH OUR FINGER. WE THEN USED OUR FINGERS TO UNDERTAKE DISSECTION ALONG THE ANTERIOR ASPECT OF THE PSOAS MUSCLE. WE THEN USED A NIM PROBE TO STIMULATE THE PSOAS TO MAKE SURE THERE WERE NO IMPORTANT STRUCTURES PASSING ABOVE IT. WITH THE HELP OF INTRAOPERATIVE IMAGING, WE THEN STARTED AT THE L4 AND L5 DISC SPACE. WE MADE SURE THAT OUR NIM PROBE WAS WELL LOCALIZED IN THE MIDDLE OF THE DISC SPACE. ONCE WE WERE S ATISFIED THAT WE WERE WELL LOCALIZED, WE THEN PIERCED THE ANNULUS WITH THE NIM PROBE. WE THEN USED A MALLET TO PUSH THE NIM PROBE EVEN FURTHER I

  Patient problems: Failure of Implant; Pain

  MAUDE report 8933789 ↗
• InjuryOct 31, 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 AT L3-4, L4-5, AND L5-S1.

  Patient problems: Injury

  MAUDE report 8026037 ↗
• InjuryOct 26, 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 PRESENTED WITH THE FOLLOWING PRE-OP DIAGNOSIS: SPONDYLOLISTHESIS, L4-5. SPONDYLOLISTHESIS, L5-S1. SHE UNDERWENT THE FOLLOWING PROCEDURES: L4-5 LAMINECTOMY, MEDIAL FACETECTOMY AND FORAMINOTOMY. L5-S1 LAMINECTOMY, MEDIAL FACETECTOMY AND FORAMINOTOMY. L4 TO THE SACRUM POSTERIOR INSTRUMENTATION, SEGMENTAL, WITH PEDICLE SCREWS. L4 TO THE SACRUM POSTEROLATERAL FUSION WITH LOCAL AUTOGRAFT AND BMP. AS PER THE OPERATIVE NOTES, ¿SHE IS BROUGHT TO THE OPERATING ROOM FOR L4 TO THE SACRUM DECOMPRESSION AND FUSION WITH POSSIBLE INTERBODY GRAFT... PATIENT UNDERSTOOD THAT WE WOULD USE BONE MORPHOGENIC PROTEIN AND LOCAL AUTOGRAFT RATHER THAN TAKE BONE GRAFT FROM HER HIP... THE WOUND WAS COPIOUSLY IRRIGATED WITH ANTIBIOTIC SOLUTION. A 16-GAUGE CATHETER WAS THEN THREADED CEPHALAD THROUGH THE RESIDUAL L4 LAMINA AND A COMBINATION OF 3.5 CC DURAMORPH AND 3.5 CC OF 0.25% MARCAINE WERE INJECTED IN THE EPIDURAL SPACE FOR POSTOPERATIVE ANALGESIA. TISSEEL FIBRIN GLUE WAS THEN USED TO ACHIEVE HEMOSTASIS IN THE EPIDURAL SPACE AND SEAL THE EPIDURAL SPACE FROM ANY ERRANT BONE MORPHOGENIC PROTEIN THAT MIGHT LEAK TOWARDS THE CANAL. COBB ELEVATORS WERE THEN U SED TO

  Patient problems: Injury

  MAUDE report 8008254 ↗
• InjuryJul 11, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2009, THE PATIENT PRESENTED WITH FOLLOWING PRE-OP DIAGNOSIS: LUMBAR SPINAL STENOSIS (724.02). LUMBOSACRAL DISK DEGENERATION (722.52). LUMBAR SPONDYLOSIS (721.3). POST LAMINECTOMY SYNDROME, LUMBAR (722.83). THE PATIENT UNDERWENT FOLLOWING PROCEDURES: L5-S1 LAMINECTOMY WITH BILATERAL PARTIAL FACETECTOMIES AND FORAMINOTOMIES WITH DECOMPRESSION OF THE NEURAL ELEMENTS. REVISION, RIGHT L4-5 HEMILAMINECTOMY WITH PARTIAL FACETECTOMY AND FORAMINOTOMY WITH DECOMPRESSION OF THE NEURAL ELEMENTS. REVISION, LEFT L4-5 HEMILAMINECTOMY, PARTIAL FACETECTOMY, AND FORAMINOTOMY WITH DECOMPRESSION OF THE NEURAL ELEMENTS. REVISION, RIGHT L3-4 HEMILAMINECTOMY WITH PARTIAL FACETECTOMY AND FORAMINOTOMY WITH DECOMPRESSION OF THE NEURAL ELEMENTS. REMOVAL OF L3-L5 POSTERIOR SEGMENTAL SPINAL INSTRUMENTATION. EXPLORATION OF L3-4 AND L4-5 POSTERIOR SPINAL FUSION. POSTEROLATERAL SPINAL FUSION, L3-4. POSTEROLATERAL SPINAL FUSION, L4-5. POSTEROLATERAL SPINAL FUSION, L5-S1. L3-S1 SEGMENTAL SPINAL INSTRUMENTATION (TITANIUM INSTRUMENTATION FROM NUVASIVE). LOCAL AUTOGRAFT BONE GRAFT HARVEST IN PREPARATION FOR SPINAL FUSION. MORSELIZED ALLOGRAFT BONE GRAFT FOR SPINAL FUSION. USE OF RHBMP-2.

  Patient problems: Injury; No Code Available

  MAUDE report 7677817 ↗
• InjuryJul 11, 2018Fitting Problem; Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2003: THE PATIENT PRESENTED WITH FOLLOWING PRE-OP DIAGNOSIS: PSEUDARTHROSIS LUMBAR SPINE, L4-L5, L5-S1. LUMBAR DEGENERATIVE INSTABILITY, L3-L4. FAILED POSTERIOR SPINAL INSTRUMENTATION, PEDICLE SCREWS IN L4 AND S1. STATUS POSTS MULTIPLE LOW BACK OPERATIONS, INCLUDING LAMINECTOMY AND INSTRUMENTED SPINAL FUSION L4 TO THE SACRUM, WITH NON-SEGMENTAL INSTRUMENTATION (STEFFEE PLATE AND SCREWS IN L4 AND 51). THE PATIENT UNDERWENT THE FOLLOWING PROCEDURES: ARTHRODESIS LUMBAR SPINE VIA RETROPERITONEAL EXPOSURE, ANTERIOR BODY FUSION L5-S1. ADDITIONAL REVEL, ARTHRODESIS LUMBAR SPINE, ANTERIOR LUMBAR INTERBODY FUSION L4-L5. ADDITIONAL LEVEL, ARTHRODESIS LUMBAR SPINE, ANTERIOR LUMBAR INTERBODY FUSION L3-L4. INSERTION OF A PROSTHETIC DEVICE IN THE INTERBODY SPACE, PEEK CAGE L5-S1. ADDITIONAL LEVEL, INSERTION OF A PROSTHETIC DEVICE IN THE INTERBODY SPACE, PEEK INTERBODY CAGE AT L4-L5. ADDITIONAL LEVEL, INSERTION OF A PROSTHETIC DEVICE IN THE INTERBODY SPACE, PEEK CAGE IN THE INTERBODY SPACE AT L3-L4. INSERTION OF BONE MORPHOGENIC PROTEIN(BMP) IN THE INTERBODY CAGES AT L3-L4, L4- L5, AND L5-S1. AS PER OPERATIVE NOTES,¿ A 16-MM ANTERIOR HEIGHT CAGE WITH AN 8- DEGREE LO

  Patient problems: Injury; No Code Available

  MAUDE report 7677011 ↗
• InjuryJun 27, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2004: THE PATIENT WAS ADMITTED FOR ELECTIVE TREATMENT OF LOW BACK PAIN. THE PATIENT UNDERWENT CT OF LUMBAR SPINE. IMPRESSION: STATUS POST SURGERY AT L3-L4 AND L4-L5. EARLY FUSION APPEARS TO BE OCCURRING. THERE IS A SMALL CENTRAL/LEFT FOCAL DISC HERNIATION AT L5-S1. IT IS A DISC PROTRUSION WITHOUT EXTRUDED DISC MATERIAL. BRIDGING BONE OSTEOTYPE ON THE RIGHT SIDE EXTENDING FROM L3-L4. SLIGHT COMPRESSION OF THE RIGHT L4 NERVE ROOT. THE PATIENT PRESENTED WITH STATUS POST FUSION L3-L4 AND L4-L5 WITH DEGENERATIVE DISC DISEASE L5-S1. THE PATIENT UNDERWENT REMOVAL OF HARDWARE FROM L3-L4-L5 WITH EVALUATION OF FUSION MASS AND REVISION OF FUSION L3-L4-L5-S1 VIA BILATERAL POSTERIOLATERAL TECHNIQUE WITH POSTERIOR LUMBAR INTERBODY FUSION OF L5-S1 WITH BILATERAL PEDICLE SCREW INSTRUMENTATION AND BMP INFUSE PRODUCT WITH LOCAL AUTOGENOUS BONE GRAFT AND MASTERGRAFT UNDER FLUOROSCOPIC GUIDANCE WITH INTRA-OP EVOKED EMG MONITORING. POST-OP DIAGNOSIS: STATUS POST FUSION L3-L4 AND L4-L5 WITH DEGENERATIVE DISC DISEASE; L5-S1 WITH PROBABLE PSEUDOARTHROSIS OF THE LUMBAR SPINE. AS PER OPERATIVE NOTES, ¿THESE AREAS WERE DECORTICATED WITH THE BUR AND THE BMP SPONGE PRODUCT WAS PLACED INTO THE LATERA

  Patient problems: Abdominal Pain; Ambulation or Postural Difficulties; Chest Pain; Claudication; Cyst(s); Depression; Dysphagia/ Odynophagia; Dyspnea; Edema; Embolus; Extraskeletal ossification; Fibrosis; Headache; Hematoma; Hematuria; Hypoxia; Incontinence; Infiltration into Tissue; Injury; Irritation; Neck Pain; Neuropathy; Numbness; Overdose; Pain; Pleural Effusion; Prolapse; Reaction; Respiratory Distress; Scarring; Stenosis; Swelling; Synovitis; Tingling; Weakness

  MAUDE report 7641259 ↗
• InjuryJun 27, 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 7640916 ↗
• InjuryJun 6, 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 PRESENTED WITH DEGENERATIVE DISC DISEASE(DDD) AND UNDERWENT TRANSFORAMINAL LUMBAR FNTERBODY FUSION (TLIF) AT L3-4, L4-5, L5-S1 IN WHICH RHBMP2/ACS WAS USED.

  Patient problems: Injury

  MAUDE report 7572956 ↗
• InjuryJun 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH PSEUDOARTHROSIS LUMBAR SPINE, FAILED INSTRUMENTATION AND UNDERWENT THE FOLLOWING PROCEDURE: REMOVAL OF INSTRUMENTATION T10-S1, REINSERTION OF PEDICLE SCREWS T10-L5, POSTERIOR LATERAL FUSION T10-S1, SEGMENTAL INSTRUMENTATION T10-S1, AND FLUOROSCOPY IN WHICH RHBMP2/ACS WAS USED. AS PER OP-NOTES,¿ PEDICLE SCREWS HAD BEEN PLACED IN SEGMENTAL FASHION FROM T10-S1. PRIOR TO THE FUSION BILATERAL RODS WERE PLACED IN THE SCREWS AND SET SCREWS WERE USED TO SECURE THE RODS TO THE SCREWS AND FINAL TIGHTENING OCCURRED AFTER CONFIRMATORY IMAGING WAS OBTAINED INCLUDING RECONNECTION TO THE ILIAC BOLT. A STACKED FOUR ROD TECHNIQUE WAS USED. THE FUSION LEVELS INCLUDE T10-S1. TO PERFORM THE FUSION A HIGH SPEED FLUTED BURR WAS USED TO DECORTICATE THE LEVELS INDICATED. FACETECTOMIES HAD BEEN PERFORMED AS WELL. ONCE THE DECORTICATION PROCESS WAS PERFORMED AND BLEEDING BONE WAS IDENTIFIED AT THE FUSION LEVELS RODS WERE PLACED WITHIN THE PEDICLE SCREWS AND SET SCREWS APPLIED WITH FINAL TIGHTENING OCCURRING. FOLLOWING THIS THE AUTOGENOUS LOCAL BONE GRAFT LISTED ABOVE WERE USED TO FACILITATE FUSION. THE WOUND WAS COPIOUSLY IRRIGATED WITH NORMAL SALINE AND HEMOST

  Patient problems: Injury

  MAUDE report 7568441 ↗
• InjuryJun 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH PSEUDOARTHROSIS LUMBAR SPINE, FAILED INSTRUMENTATION AND UNDERWENT THE FOLLOWING PROCEDURE: REMOVAL OF INSTRUMENTATION T10-S1, REINSERTION OF PEDICLE SCREWS T10-L5, POSTERIOR LATERAL FUSION T10-S1, SEGMENTAL INSTRUMENTATION T10-S1, AND FLUOROSCOPY IN WHICH RHBMP2/ACS WAS USED. AS PER OP-NOTES,¿ PEDICLE SCREWS HAD BEEN PLACED IN SEGMENTAL FASHION FROM T10-S1. PRIOR TO THE FUSION BILATERAL RODS WERE PLACED IN THE SCREWS AND SET SCREWS WERE USED TO SECURE THE RODS TO THE SCREWS AND FINAL TIGHTENING OCCURRED AFTER CONFIRMATORY IMAGING WAS OBTAINED INCLUDING RECONNECTION TO THE ILIAC BOLT. A STACKED FOUR ROD TECHNIQUE WAS USED. THE FUSION LEVELS INCLUDE T10-S1. TO PERFORM THE FUSION A HIGH SPEED FLUTED BURR WAS USED TO DECORTICATE THE LEVELS INDICATED. FACETECTOMIES HAD BEEN PERFORMED AS WELL. ONCE THE DECORTICATION PROCESS WAS PERFORMED AND BLEEDING BONE WAS IDENTIFIED AT THE FUSION LEVELS RODS WERE PLACED WITHIN THE PEDICLE SCREWS AND SET SCREWS APPLIED WITH FINAL TIGHTENING OCCURRING. FOLLOWING THIS THE AUTOGENOUS LOCAL BONE GRAFT LISTED ABOVE WERE USED TO FACILITATE FUSION. THE WOUND WAS COPIOUSLY IRRIGATED WITH NORMAL SALINE AND HEMOST

  Patient problems: Injury

  MAUDE report 7568436 ↗
• 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 7543902 ↗
• InjuryMay 23, 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 SUR GERY. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: Injury

  MAUDE report 7539398 ↗
• InjuryMay 22, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT THE FOLLOWING PROCEDURES: POSTERIOR T7-T9 LAMINECTOMY FUSION, RE-DO L4-S1 LAMINECTOMY, REVISION FUSION, PSEUDOARTHROSIS, RE-DO L4-5, L5-S1 INTERBODY FUSION, SSEP IN WHICH RHBMP-2/ACS WAS USED. POST-OP,THE PATIENT SUSTAINED UNSPECIFIED INJURIES FOLLOWING THE USE OF RHBMP-2/ACS.

  Patient problems: Injury

  MAUDE report 7535720 ↗
• InjuryMay 22, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT THE FOLLOWING PROCEDURES: POSTERIOR T7-T9 LAMINECTOMY FUSION, RE-DO L4-S1 LAMINECTOMY, REVISION FUSION, PSEUDOARTHROSIS, RE-DO L4-5, L5-S1 INTERBODY FUSION, SSEP IN WHICH RHBMP-2/ACS WAS USED. POST-OP,THE PATIENT SUSTAINED UNSPECIFIED INJURIES FOLLOWING THE USE OF RHBMP-2/ACS.

  Patient problems: Injury

  MAUDE report 7535719 ↗
• InjuryMay 16, 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 RHBMP2/ACS WAS USED.

  Patient problems: Injury

  MAUDE report 7517662 ↗
• 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 ANTERIOR <(>&<)> POSTERIOR FUSION SURGERY AT L4-S1 IN WHICH RHBMP-2/ACS WAS USED. POST-OP, IT WAS REPORTED THAT THE PATIENT ALLEGEDLY SUSTAINED UNSPECIFIED INJURIES RESULTING FROM THE PROCEDURE. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Injury

  MAUDE report 7498464 ↗
• InjuryApr 27, 2018Adverse 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 UNDERWENT LAMINECTOMY L3-4, POSTERIOR LUMBAR FUSION SURGERY AT L3-4 IN WHICH RHBMP-2 WAS USED. POST-OP, PATIENTS SUSTAINED UNSPECIFIED INJURIES.

  Patient problems: Injury

  MAUDE report 7469977 ↗
• InjuryApr 26, 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: STATUS POST POSTERIOR INSTRUMENTED FUSION WITH FIRST -GENERATION CD IMPLANTS T4-L4. STATUS POST ANTERIOR SINGLE SCREW, SINGLE ROD FUSION T10-L4. SURGERIES 16-17 YEARS AGO FOR SCOLIOSIS. NONUNION AT L3-L4. SUBSEQUENT SEVERE DISC DEGENERATION AT L3-L4, L4-L5 AND L5-S1, WITH MILD CORONAL AND SAGITTAL IMBALANCE. THE PATIENT UNDERWENT THE FOLLOWING PROCEDURES: APPLICATION OF HALO AND HALO TRACTION, PARTIAL REMOVAL OF THE FIRST-GENERATION CD INSTRUMENTATION POSTERIORLY, REVISION POSTERIOR SEGMENTAL SPINAL INSTRUMENTATION FROM T11 TO THE SACRUM AND PELVIS BILATERALLY, POSTEROLATERAL SPINAL FUSION L3-L4, L4-L5 AND L5-S1, 35 ML LOCAL BONE GRAFT, 25 CC FRESH FROZEN FEMORAL HEAD/ALLOPAC, 120 MG BMP ON 60 ML CRM SPONGES, SOMATOSENSORY POTENTIAL MONITORING, PERCUTANEOUS MOTOR-EVOKED POTENTIAL MONITORING. AS PER OP-NOTES, ¿I THEN PLACED THE BONE GRAFT MIXTURE. THE 60 ML CRM SPONGE SOAKED WITH 120 MG BMP. THE PROCEDURE WAS 50% OR SO HARDER THAN A STANDARD PROCEDURE BECAUSE OF THE SCAR TISSUE WE HAD TO DISSECT OFF FROM L3 TO THE SACRUM AND SOMEWHAT MORE DIFFICULT TO GET OUR FIXATION POINTS, BECAUSE A LOT OF THE FIXATIO

  Patient problems: Ambulation or Postural Difficulties; Headache; Neuropathy; Numbness; Pain

  MAUDE report 7464900 ↗
• InjuryApr 26, 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: STATUS POST POSTERIOR INSTRUMENTED FUSION WITH FIRST -GENERATION CD IMPLANTS T4-L4. STATUS POST ANTERIOR SINGLE SCREW, SINGLE ROD FUSION T10-L4. SURGERIES 16-17 YEARS AGO FOR SCOLIOSIS. NONUNION AT L3-L4. SUBSEQUENT SEVERE DISC DEGENERATION AT L3-L4, L4-L5 AND L5-S1, WITH MILD CORONAL AND SAGITTAL IMBALANCE. THE PATIENT UNDERWENT THE FOLLOWING PROCEDURES: APPLICATION OF HALO AND HALO TRACTION, PARTIAL REMOVAL OF THE FIRST-GENERATION CD INSTRUMENTATION POSTERIORLY, REVISION POSTERIOR SEGMENTAL SPINAL INSTRUMENTATION FROM T11 TO THE SACRUM AND PELVIS BILATERALLY, POSTEROLATERAL SPINAL FUSION L3-L4, L4-L5 AND L5-S1, 35 ML LOCAL BONE GRAFT, 25 CC FRESH FROZEN FEMORAL HEAD/ALLOPAC, 120 MG BMP ON 60 ML CRM SPONGES, SOMATOSENSORY POTENTIAL MONITORING, PERCUTANEOUS MOTOR-EVOKED POTENTIAL MONITORING. AS PER OP-NOTES, ¿I THEN PLACED THE BONE GRAFT MIXTURE. THE 60 ML CRM SPONGE SOAKED WITH 120 MG BMP. THE PROCEDURE WAS 50% OR SO HARDER THAN A STANDARD PROCEDURE BECAUSE OF THE SCAR TISSUE WE HAD TO DISSECT OFF FROM L3 TO THE SACRUM AND SOMEWHAT MORE DIFFICULT TO GET OUR FIXATION POINTS, BECAUSE A LOT OF THE FIXATIO

  Patient problems: Ambulation or Postural Difficulties; Headache; Neuropathy; Numbness; Pain

  MAUDE report 7464894 ↗
• InjuryApr 26, 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: STATUS POST POSTERIOR INSTRUMENTED FUSION WITH FIRST -GENERATION CD IMPLANTS T4-L4. STATUS POST ANTERIOR SINGLE SCREW, SINGLE ROD FUSION T10-L4. SURGERIES 16-17 YEARS AGO FOR SCOLIOSIS. NONUNION AT L3-L4. SUBSEQUENT SEVERE DISC DEGENERATION AT L3-L4, L4-L5 AND L5-S1, WITH MILD CORONAL AND SAGITTAL IMBALANCE. THE PATIENT UNDERWENT THE FOLLOWING PROCEDURES: APPLICATION OF HALO AND HALO TRACTION, PARTIAL REMOVAL OF THE FIRST-GENERATION CD INSTRUMENTATION POSTERIORLY, REVISION POSTERIOR SEGMENTAL SPINAL INSTRUMENTATION FROM T11 TO THE SACRUM AND PELVIS BILATERALLY, POSTEROLATERAL SPINAL FUSION L3-L4, L4-L5 AND L5-S1, 35 ML LOCAL BONE GRAFT, 25 CC FRESH FROZEN FEMORAL HEAD/ALLOPAC, 120 MG BMP ON 60 ML CRM SPONGES, SOMATOSENSORY POTENTIAL MONITORING, PERCUTANEOUS MOTOR-EVOKED POTENTIAL MONITORING. AS PER OP-NOTES, ¿I THEN PLACED THE BONE GRAFT MIXTURE. THE 60 ML CRM SPONGE SOAKED WITH 120 MG BMP. THE PROCEDURE WAS 50% OR SO HARDER THAN A STANDARD PROCEDURE BECAUSE OF THE SCAR TISSUE WE HAD TO DISSECT OFF FROM L3 TO THE SACRUM AND SOMEWHAT MORE DIFFICULT TO GET OUR FIXATION POINTS, BECAUSE A LOT OF THE FIXATIO

  Patient problems: Ambulation or Postural Difficulties; Headache; Neuropathy; Numbness; Pain

  MAUDE report 7464884 ↗
• InjuryApr 26, 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: STATUS POST POSTERIOR INSTRUMENTED FUSION WITH FIRST -GENERATION CD IMPLANTS T4-L4. STATUS POST ANTERIOR SINGLE SCREW, SINGLE ROD FUSION T10-L4. SURGERIES 16-17 YEARS AGO FOR SCOLIOSIS. NONUNION AT L3-L4. SUBSEQUENT SEVERE DISC DEGENERATION AT L3-L4, L4-L5 AND L5-S1, WITH MILD CORONAL AND SAGITTAL IMBALANCE. THE PATIENT UNDERWENT THE FOLLOWING PROCEDURES: APPLICATION OF HALO AND HALO TRACTION, PARTIAL REMOVAL OF THE FIRST-GENERATION CD INSTRUMENTATION POSTERIORLY, REVISION POSTERIOR SEGMENTAL SPINAL INSTRUMENTATION FROM T11 TO THE SACRUM AND PELVIS BILATERALLY, POSTEROLATERAL SPINAL FUSION L3-L4, L4-L5 AND L5-S1, 35 ML LOCAL BONE GRAFT, 25 CC FRESH FROZEN FEMORAL HEAD/ALLOPAC, 120 MG BMP ON 60 ML CRM SPONGES, SOMATOSENSORY POTENTIAL MONITORING, PERCUTANEOUS MOTOR-EVOKED POTENTIAL MONITORING. AS PER OP-NOTES, ¿I THEN PLACED THE BONE GRAFT MIXTURE. THE 60 ML CRM SPONGE SOAKED WITH 120 MG BMP. THE PROCEDURE WAS 50% OR SO HARDER THAN A STANDARD PROCEDURE BECAUSE OF THE SCAR TISSUE WE HAD TO DISSECT OFF FROM L3 TO THE SACRUM AND SOMEWHAT MORE DIFFICULT TO GET OUR FIXATION POINTS, BECAUSE A LOT OF THE FIXATIO

  Patient problems: Ambulation or Postural Difficulties; Headache; Neuropathy; Numbness; Pain

  MAUDE report 7464883 ↗
• InjuryApr 26, 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: STATUS POST POSTERIOR INSTRUMENTED FUSION WITH FIRST -GENERATION CD IMPLANTS T4-L4. STATUS POST ANTERIOR SINGLE SCREW, SINGLE ROD FUSION T10-L4. SURGERIES 16-17 YEARS AGO FOR SCOLIOSIS. NONUNION AT L3-L4. SUBSEQUENT SEVERE DISC DEGENERATION AT L3-L4, L4-L5 AND L5-S1, WITH MILD CORONAL AND SAGITTAL IMBALANCE. THE PATIENT UNDERWENT THE FOLLOWING PROCEDURES: APPLICATION OF HALO AND HALO TRACTION, PARTIAL REMOVAL OF THE FIRST-GENERATION CD INSTRUMENTATION POSTERIORLY, REVISION POSTERIOR SEGMENTAL SPINAL INSTRUMENTATION FROM T11 TO THE SACRUM AND PELVIS BILATERALLY, POSTEROLATERAL SPINAL FUSION L3-L4, L4-L5 AND L5-S1, 35 ML LOCAL BONE GRAFT, 25 CC FRESH FROZEN FEMORAL HEAD/ALLOPAC, 120 MG BMP ON 60 ML CRM SPONGES, SOMATOSENSORY POTENTIAL MONITORING, PERCUTANEOUS MOTOR-EVOKED POTENTIAL MONITORING. AS PER OP-NOTES, ¿I THEN PLACED THE BONE GRAFT MIXTURE. THE 60 ML CRM SPONGE SOAKED WITH 120 MG BMP. THE PROCEDURE WAS 50% OR SO HARDER THAN A STANDARD PROCEDURE BECAUSE OF THE SCAR TISSUE WE HAD TO DISSECT OFF FROM L3 TO THE SACRUM AND SOMEWHAT MORE DIFFICULT TO GET OUR FIXATION POINTS, BECAUSE A LOT OF THE FIXATIO

  Patient problems: Ambulation or Postural Difficulties; Headache; Neuropathy; Numbness; Pain

  MAUDE report 7464882 ↗

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-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-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-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