INFUSE® Bone Graft 7510600Recalls & reported problems

Summary

The FDA's MAUDE database contains 69 adverse event reports that list this exact device (DI 00681490843812), received between Nov 17, 2016 and Jul 18, 2024 — classified as 69 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); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 69 reports, in the reporter's own words as published by the FDA.

• InjuryJul 18, 2024Osseointegration Problem; Osseointegration Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH POSTERIOR FUSION THERAPY. LEVELS IMPLANTED C2-T2. INFUSE IS INDICATED FOR USE IN CERTAIN LUMBAR INTERBODY FUSION PROCEDURES. INFORMATION GIVEN DESCRIBES A POSTERIOR CERVICOTHORACIC FUSION. IT WAS REPORTED THAT THE REVISION FOR FAILED HARDWARE PERFORMED (B)(6). PATIENT BECAME SEPTIC ON (B)(6), BLOOD CULTURES RESULTED WITH SERRATIA MARCESCENS AND VANCOMYCIN RESISTANT ENTEROCOCCUS FAECIUM. I & D PERFORMED ON (B)(6). WOUND, TISSUE AND BONE CULTURES COLLECTED ON 6/19 WITH MATCHING ORGANISMS. PATIENT POD#6 D AND EXTENSIVE SURGICAL DEBRIDEMENT OF BONE AND PURULENT TISSUE, RECOVERING ON ANTIBIOTICS FOR SERRATIA MARCESCENS AND VRE IN SURGICAL SITE AND BLOOD. STABLE CONDITION ON MEDICAL FLOOR.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Bacterial Infection; Sepsis

  MAUDE report 19769200 ↗
• InjuryJul 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PER PATIENT CALL THAT ON UNKNOWN DATE, POST-OP, NERVE DAMAGE WAS REPORTED. HENCE, ON AN UNKNOWN DATE IN 2007, PATIENT UNDERWENT A REVISION SURGERY. AGAIN IN 2010, PATIENT UNDERWENT AN EMERGENCY REVISION SURGERY AS THE IMPLANTED SCREW LOOSENED. THE LOOSENED SCREW WAS REPLACED IN THIS REVISION SURGERY. REPORTEDLY, PATIENT CONTINUES TO EXPERIENCE PAIN AND MUSCLE TENSION.

  Patient problems: Nerve Damage; Pain

  MAUDE report 8789983 ↗
• InjuryJul 2, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON: (B)(6) 2005: THE PATIENT PRESENTED WITH L3 THROUGH L5 LUMBAR DEGENERATIVE DISC DISEASE. THE PATIENT UNDERWENT THE FOLLOWING PROCEDUR ES: SECOND STAGE OF PLANNED TWO-STAGE OPERATIVE PROCEDURE, POSTERIOR L3 THROUGH L5 INSTRUMENTED FUSION WITH BMP (BONE MORPHOGENIC PROTEIN), CORTICOCANCELLOUS ALLOGRAFT, AND DEMINERALIZED BONE MATRIX. AS PER THE OPERATIVE NOTES, ¿A STRIP OF BMP (BONE MORPHOGENIC PROTEIN) WAS PLACED IN THE INTER-TRANSVERSE POSITION BILATERALLY BETWEEN L3 AND L4 AS WELL AS L4 AND L5.¿ NO INTRA-OPERATIVE COMPLICATIONS WERE REPORTED.

  Patient problems: Injury

  MAUDE report 7654135 ↗
• InjuryJun 27, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT UNSPECIFIED FUSION SURGERY AT L2-3, L3-4, L4-5 AND L5-S1 IN WHICH RHBMP-2/ACS WAS USED. POST-OP, PATIENT REPORTEDLY SUSTAINED UNSPECIFIED INJURIES.

  Patient problems: Injury

  MAUDE report 7641208 ↗
• InjuryJun 20, 2018Adverse 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 UNDERWENT AN ANTERIOR LUMBAR INTERBODY FUSION AND POSTEROLATERAL FUSION SURGERY, AND A POSTERIOR THORACOLUMBAR FUSION SURGERY ON THE LUMBAR REGION OF HER SPINE FROM VERTEBRAE L1 TO S1. REPORTEDLY, PATIENT WAS IMPLANTED WITH RHBMP-2/ACS IN THIS SURGERY. THE RHBMP-2 COLLAGEN SPONGE WAS PLACED OUTSIDE A CAGE, I.E., IN THE POSTEROLATERAL REGION. ALLEGEDLY, THE PATIENT'S POST-OPERATIVE PERIOD WAS MARKED BY ¿A PERIOD OF IMPROVEMENT FOLLOWED BY INCREASING PAIN IN HER LOW BACK AND BUTTOCKS¿. IT WAS REPORTED THAT THE PATIENT PRESENTED WITH THE FOLLOWING PRE-OP DIAGNOSIS: RECALCITRANT LUMBAGO. MULTILEVEL SEGMENTAL LUMBAR SPINAL STENOSIS WITH FORAMINAL STENOSIS. DEGENERATIVE LUMBAR DISK DISEASE. DEGENERATIVE SPONDYLOLISTHESIS. DEGENERATIVE SCOLIOSIS. THE PATIENT UNDERWENT THE FOLLOWING PROCEDURES: ANTERIOR LUMBAR INTERBODY FUSION VIA LEFT-SIDED RETROPERITONEAL APPROACH, L4-L5, L5-S1. PLACEMENT OF INTRADISCAL SPACER, L4-L5 AND LS-S1. ANTERIOR SPINAL INSTRUMENTATION WITH TITANIUM VERTEBRAL RETENTION SCREWS L4 AND S1. USE OF BMP. LOCAL BONE GRAFTING. AS PER OPERATIVE NOTES, ¿ THE SPACER WAS FILLED WITH BMP, TAMPED INTO POSITION WITH EXCELLENT INT

  Patient problems: Pain

  MAUDE report 7618677 ↗
• InjuryJun 18, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON: (B)(6) 2004: THE PATIENT PRESENTED WITH THE FOLLOWING PRE-OP DIAGNOSIS: CHRONIC LOWER BACK PAIN WITH DEGENERATIVE DISC DISEASE. THE PATIENT UNDERWENT TRANSPERITONEAL ANTERIOR EXPOSURE OF LUMBAR SPINE AND ON-Q PAIN REDUCTION CATHETER PLACEMENT. AS PER THE OPERATIVE NOTES,¿ THE REST OF THE SOFT TISSUE STRUCTURE AT THE L3-L4 WAS FREED WITH DISSECTOR. THE SURGEON THEN SUBSEQUENTLY PERFORMED THE ANTERIOR LUMBAR INTERBODY FUSION AT L3-L4 AND L4-L5 AND L5-S1. THE SURGEON SUBSEQUENTLY PERFORMED THE POSTERIOR LUMBAR INTERBODY FUSION WITH PEDICLE SCREW FIXATION, RHBMP-2/ACS WAS USED IN THE PROCEDURE.¿ NO INTRA-OPERATIVE COMPLICATIONS WERE REPORTED.

  Patient problems: Injury

  MAUDE report 7608855 ↗
• InjuryJun 13, 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 OPERATIVE DIAGNOSIS: LUMBAR SPONDYLOSIS, DEGENERATIVE DISK DISEASE AND KYPHOSIS AND RADICULITIS. SHE UNDERWENT THE FOLLOWING PROCEDURES: L4-5 AND L5-S1 POSTEROLATERAL FUSION, L4-5 AND L5-S1 TRANSFORAMINAL LUMBAR INTERBODY FUSION; L4-5 AND L5-S1 ANTERIOR INTERBODY DEVICE APPLICATION; LA, L5 OSTEOTOMIES AND SEGMENTAL INSTRUMENTATION. AS PER THE OPERATIVE NOTES, ¿I PERFORMED A THOROUGH DISKECTOMY FROM THE RIGHT HAND SIDE USING A 15 BLADE FOLLOWED BY DISK SHAVERS AND SHAPERS AND DOWN GOING AND CROSS GOING CURETTES. AFTER TRIALING FOR SIZE, I IMPACTED THE APPROPRIATE SIZED INTERBODY CAGE FILLED WITH BMP IN THE INTERSPACE WITH INFUSE AND LOCAL GRAFT BURRITO WRAPPED BEHIND THAT AND MORE GRAFT PACKED BEHIND THAT.¿ NO INTRA OPERATIVE COMPLICATIONS WERE REPORTED.

  Patient problems: Injury

  MAUDE report 7595231 ↗
• InjuryJun 1, 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: DEGENERATIVE JOINT DISEASE, DISC SPACE L5-S1 AND DISC SPACE L4-5. POSTLAMINECTOMY INSTABILITY L5-S1. INTERNAL DISC DERANGEMENT L4-5, L5-S1. PATIENT UNDERWENT FOLLOWING PROCEDURES: ANTERIOR APPROACH FOR ANTERIOR DISCECTOMY, LUMBAR FUSION WITH CAGES AND BONE MORPHOGENIC PROTEIN, PLACEMENT OF ANTERIOR PLATES. ANTERIOR RETROPERITONEAL APPROACH L4-5, L5-S1. COMPLETE DISCECTOMY L4-5, L5-S1. ANTERIOR INTERBODY FUSION WITH BONE MORPHOGENIC PROTEIN AND CAGE L4-5, L5-S1. 5. FIXATION WITH PLATE L4-5, L5-S1. AS PER OPERATIVE NOTES, "A SERIES OF SIZING DEVICES WERE USED AND A 10 DEGREE 14MM, MEDIUM SIZE CAGE WAS CHOSEN AND IMPLANTED WITH BONE MORPHOGENIC PROTEIN IN THE SUBSTANCE OF THE CAGE. THE FIT SEEMED QUITE GOOD. A 43 MM L5-S1 PLATE WAS CHOSEN, IMPLANTED WITH 24 MM SCREWS. SIZING DEVICES WERE AGAIN USED AND A 16 MM,5 DEGREE, MEDIUM SIZE CAGE WAS IMPLANTED WITH BONE MORPHOGENIC PROTEIN WITHIN THE SUBSTANCE OF THE CAGE. THE FIT SEEMED QUITE GOOD. A 43 MM L4-5 PLATE WAS; CHOSEN AND IMPLANTED WITH 26 MM SCREWS." NON INTRA-OPERATIVE COMPLICATIONS WERE REPORTED. ON (B)(6) 2007 THE PATIENT GOT DISCHARGED FROM THE FACILITY

  Patient problems: Ambulation or Postural Difficulties; Fall; Inadequate Pain Relief; Muscle Spasm(s); Neuropathy; Pain; Swelling

  MAUDE report 7559817 ↗
• InjuryMay 22, 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 OPERATIVE DIAGNOSIS: RECURRENT LUMBAR SPINAL STENOSIS. MOBILE SP ONDYLOLISTHESIS L4-5. DEGENERATIVE DISK DISEASE. DIABETES MELLITUS. HE UNDERWENT THE FOLLOWING PROCEDURES: LEFT L4-5 AND LS-S1 ANTERIOR LUMBAR INTERBODY FUSION WITH PEEK, DEMINERALIZED BONE MATRIX AND BMP. INSERTION OF INTERBODY DEVICE L4-5 AND L5-S1. APPLICATION OF ANTERIOR SPINAL INSTRUMENTATION L4-5 AND LS-S1. RETROPERITONEAL APPROACH TO THE ANTERIOR SPINE. REVISION L4 THROUGH S1 POSTERIOR SPINAL DECOMPRESSION WITH ASSOCIATED MEDIAL FACETECTOMIES, FORAMINOTOMIES, AND LATERAL RECESS DECOMPRESSION. L3 THROUGH S1 POSTERIOR SPINAL FUSION USING LOCAL AUTOGRAFT ALLOGRAFT DEMINERALIZED BONE MATRIX AND BMP. POSTERIOR SPINAL INSTRUMENTATION L3 TO S1. AS PER THE OPERATIVE NOTES, ¿A 13-DEGREE LORDOTIC CAGE WAS USED. SIMULTANEOUS TO PREPARATION FOR END PLATES, TWO LARGE BMP KITS WERE PREPARED. ADDITIONALLY, A 10-CC DEMINERALIZED BONE MATRIX WAS PREPARED. FOUR BMP SPONGES WERE WRAPPED AROUND SOME DEMINERALIZED BONE MATRIX AND PACKED INTO OUR CAGE. AT LS-S1, SEVERAL DISTRACTORS AND TRIAL SPACERS WERE INSERTED. ULTIMATELY, A 41-RNM WIDE X SO MM HIGH CAGE WAS

  Patient problems: Pain

  MAUDE report 7532501 ↗
• 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 ANTERIOR LUMBAR FUSION SURGERY USING RHBMP-2 ON (B)(6) 2011. POST-OP, PATIENT ALLEGEDLY SUSTAINED UNSPECIFIED INJURIES FROM THIS SPINAL FUSION SURGERY . NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Injury

  MAUDE report 7517641 ↗
• InjuryApr 27, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT POSTERIOR LUMBAR INTERBODY FUSION (PLIF) SURGERY AT L3-L5 IN WHICH RHBMP2/ACS WAS USED.

  Patient problems: Injury

  MAUDE report 7467765 ↗
• InjuryApr 14, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT ANTERIOR FUSION SURGERY AT L3-S1 IN WHICH RHBMP-2/ACS WAS USED.

  Patient problems: Injury

  MAUDE report 7431576 ↗
• InjuryApr 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON: (B)(6) 2016: THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH STATUS POST FUSION L3-S1 WITH PEDICLE SCREW INSTRUMENTATION. SEVERE SPINAL STENOSIS, L2-L3 WITH FIXED SAGITTAL IMBALANCE AND UNDERWENT THE FOLLOWING PROCEDURES: EXPLORATION OF FUSION AND REMOVAL OF HARDWARE L3-S1. POSTERIOR BASED OSTEOTOMY, L2-L3. PEDICLE SCREW INSTRUMENTATION, L1-S1 .POSTEROLATERAL LUMBAR FUSION, L1-L2, L2-L3, L3-L4, L4-L5, AND L5-S1. DIRECT LATERAL INTERBODY FUSION THROUGH RETROPERITONEAL APPROACH WITH PLACEMENT OF ANTERIOR LUMBAR INTERBODY CAGE, L2-L3 SUPPLEMENTED WITH BONE MORPHOGENIC PROTEIN (BMP). AS PER OPERATIVE NOTES,¿ THE CAGE WAS PLACED FROM THE ANTERIOR APPROACH. IT WAS TAMPED DOWN SLIGHTLY TO MOVE INTO A BETTER POSITION FOR CORRECTION OF THE DEFORMITY. THIS WAS DONE WITHOUT COMPLICATION. RODS WERE CONTOURED APPROPRIATELY. APPROPRIATE IN SITU CORRECTION WAS USED. RODS WERE CONTOURED FROM L1-S1, SCREW TESTING WAS DONE, THERE WERE NO COMPLICATIONS. THE TRANSVERSE PROCESS AND LAMINA WERE DECORTICATED. BONE GRAFT SUBSTITUTE AND ALLOGRAFT BONE WAS PLACED POSTEROLATERALLY. A DEEP DRAIN WAS PLACED. THE FASCIA WAS CLOSED. THE SKIN WAS CLOSED IN LAYERS.¿ THE PATIENT TOLERATED TH

  Patient problems: Injury

  MAUDE report 7401805 ↗
• InjuryMar 30, 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 FUSION SURGERY IN WHICH RHBMP-2/ACS WAS USED.

  Patient problems: Injury

  MAUDE report 7384497 ↗
• InjuryMar 23, 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 L4-5 AND L5-S1 DISC HERNIATION WITH RADICULOPATHY AND DISKOGENIC BACK PAIN AND UNDERWENT THE FOLLOWING PROCEDURES: ANTERIOR LUMBAR INTERBODY FUSION AT L4-5 AND ANTERIOR LUMBAR INTERBODY FUSION AT L5-S1. BIOMECHANICAL DEVICE WITH LT CAGES PAIRED AT L5-S1. DISCECTOMY ANTERIORLY AT L4-5 AND DISCECTOMY ANTERIOR AT L5-S1. C-ARM FOR LOCALIZATION OF DEVICE. ALLOGRAFT NONSTRUCTURAL. AS PER OP-NOTES,¿ THE DECOMPRESSION WAS PERFORMED BACK TO THE SPINAL CANAL AND REDUNDANT ANNULUS AND CLEAR CENTRAL DISC HERNIATIONS WERE REMOVED WITH PITUITARY AND CURETTE. AGAIN THE DISCECTOMY WAS OVER AND ABOVE THE SIMPLE BLOCK DISCECTOMY. BMP AND ALLOGRAFT WERE ALLOWED TO PREPARE ACCORDING TO PROTOCOL. DEEP TO THE CAGES, WE DID PLACE CRUSHED CANCELLOUS ALLOGRAFT FOLLOWED BY BMP SPONGES AS WELL AS THE CAGES COUNTERSUNK TO 6 MM. AGAIN ATTENTION WAS TURNED TO THE L4-5 LEVEL. THE DISC WAS REMOVED IN TO RESECTING THE DISC COMPLETELY, RELEASING AND RESECTING THE ANNULUS AND RELEASING PORTIONS OF THE POSTERIOR LONGITUDINAL LIGAMENT ALL THE WAY TO THE POSTEROLATERAL COMERS FAR, ABOVE AND OVER THE SIMPLE BLOCK DISCECTOMY. THE DECOMPRESSION WAS PERFOR

  Patient problems: Ambulation or Postural Difficulties; Burning Sensation; Neuropathy; Pain

  MAUDE report 7364872 ↗
• InjuryMar 17, 2018Adverse 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.

  Patient problems: Injury

  MAUDE report 7347570 ↗
• InjuryMar 9, 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 SEGMENTAL INSTABILITY WITH STENOSIS AND FACET ARTHROPATHY L4-5, L5-S1 AND UNDERWENT THE FOLLOWING PROCEDURES: ANTERIOR PERITONEAL APPROACH L4-5 AND L5-S1. COMPLETE DISCECTOMY L4-5 AND L5-S1. ANTERIOR INTERBODY FUSION WITH BONE MORPHOGENIC PROTEIN AND CAGE, L5-S1. SPINAL INSTRUMENTATION WITH ANTERIOR CERVICAL PLATE L4-5 AND L5-S1. AS PER OP-NOTES,¿ THE COMPLETE DISK WAS REMOVED. THE POSTERIOR LONGITUDINAL LIGAMENT WAS RELEASED. A COMPLETE DISKECTOMY WAS PERFORMED. REMOVAL OF THE ENTIRE DISK WAS DONE AND THE END PLATES WERE FASHIONED OUT. A SERIES OF SIZING DEVICES WERE USED. A 14-MM 10-DEGREE MEDIUM SIZED CAGE WAS CHOSEN AND IMPLANTED WITH BONE MORPHOGENIC PROTEIN WITHIN THE SUBSTANCE OF THE CAGE. A 43-MM L5-S1 PLATE WAS CHOSEN AND IMPLANTED WITH 22-MM SCREWS. ALL CONNECTIONS WERE CHECKED AND DOUBLE CHECKED WITH A TORQUE DEVICE. ATTENTION WAS THEN TURNED TO THE L4-5 LEVEL WHERE ANNULUS WAS INCISED IN A 10 O'CLOCK TO 2 O'CLOCK FASHION AND A SERIES OF ELEVATORS AND CURETTES WERE USED TO ELEVATE THE DISK FROM THE VERTEBRAL BODY END PLATES AND REMOVED THE COMPLETE DISK. POSTERIOR LONGITUDINAL LIGAMENT WAS RELEASED. THE

  Patient problems: Injury

  MAUDE report 7326408 ↗
• InjuryMar 1, 2018Adverse 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 UNDERWENT ANTERIOR LUMBAR INTERBODY FUSION SURGERY FROM VERTEBRAE L4 TO S1. REPORTEDLY, RHBMP-2/ACS WAS USED IN THIS SURGERY. THE RHBMP-2 COLLAGEN SPONGE WAS USED TO FUSE MORE THAN ONE LEVEL OF THE SPINE. POST-OP, THE PATIENT SUFFERED FROM INCREASING LOW BACK PAIN, NUMBNESS IN HER LEFT GROIN, AND PAIN AND RADICULOPATHY IN HER LEFT LEG. SEVERE PAIN AND SYMPTOMS ULTIMATELY COMPELLED PATIENT TO UNDERGO A RISKY, PAINFUL AND COSTLY REVISION SURGERY ON (B)(6) 2003. DESPITE REVISION SURGERY, PATIENT PAIN AND RELATED SYMPTOMATOLOGY RETURNED. PATIENT CONTINUED TO EXPERIENCE CHRONIC AND EXTREME BACK PAIN THAT RADIATES UP AND DOWN HER SPINE AND INTO HER LEGS, NUMBNESS AND TINGLING FROM HER BUTTOCKS DOWN TO HER FEET, AND SWELLING IN HER LEGS AND FEET. PATIENT WAS CONSTANTLY SITTING OR LYING DOWN, HAD DIFFICULTY IN WALKING, AND EXPERIENCES BLADDER AND BOWEL ISSUES. PATIENT REQUIRED A CANE FOR ASSISTANCE ON OCCASION AND SUFFERS FROM DEPRESSION. THESE SERIOUS INJURIES PREVENT PATIENT FROM PRACTICING AND ENJOYING THE ACTIVITIES OF DAILY LIFE. THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH INTERNAL DISC DERANGEMENT, L4-L5 AND L5-S1 AND UNDERWENT THE

  Patient problems: Ambulation or Postural Difficulties; Depression; Inadequate Pain Relief; Neuropathy; Numbness; Pain; Swelling; Tingling

  MAUDE report 7307702 ↗
• InjuryDec 29, 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 WAS PRE-OPERATIVELY DIAGNOSED WITH: PSEUDOARTHROSIS. STENOSIS, L4-5. LUMBAR RADICULOPATHY. HE UNDERWENT THE FOLLOWING PROCEDURES: REMOVAL OF HARDWARE. DECOMPRESSION LAMINECTOMY, FORAMINOTOMY AND PARTIAL FACETECTOMY, L4-5. POSTERIOR SPINAL FUSION, L4-5. USE OF LOCAL BONE, ALLOGRAFT AND BMP. VANE INSTRUMENTATION APPLIED. REMOVAL OF OLD HARDWARE. AS PER OP-NOTES,¿ AFTER VERIFYING LEVELS, THE OLD HARDWARE WAS EXPOSED. AGAIN, DUE TO THE TRAJECTORY, THIS WAS A VERY DIFFICULT TRAJECTORY TO PERFORM. AFTER MAKING INITIAL EXPOSURE TO REMOVE THE OLD HARDWARE, THE ROD, CAP AND SCREWS WERE REMOVED. AT THIS POINT, NEW TRAJECTORIES WERE MADE FOR ALL SCREWS TO GET BETTER PURCHASE AND THEN THESE WERE LEFT OPEN, AT WHICH POINT, THE LATERAL GUTTERS AND PARS WERE THEN EXPOSED. NEXT, THE OVERLYING SCAR TISSUE AND DURA WAS THEN DEBRIDED AND THERE WAS A DURAL BLEB WHICH WAS ENCOUNTERED IN THE DECOMPRESSION WHICH WAS OVER SEWN WITH A 6-0 SILK. AFTER SECURING THE DURAL BLEB, THIS WAS THE COMPLETION OF THE DECOMPRESSION AGAIN WITH A FAIR AMOUNT OF THE LAMINA WHICH WAS RESECTED, AS WELL AS A THICKENED FLAVUM FACET COMPLEX AND 4 AND L5 ROOTS WERE TRACED TO THE

  Patient problems: Extraskeletal ossification; Neuropathy

  MAUDE report 7153746 ↗
• InjuryDec 27, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SPINE FUSION SURGERY ON CERVICAL AND THORACIC REGION OF SPINE FROM VERTEBRAE C2 TO T2. THE RHBMP-2 AND COLLAGEN SPONGE WERE USED IN THE SURGERY. POST-OP, PATIENT EXPERIENCED PROGRESSIVELY WORSENING AND CHRONIC NECK AND BACK PAIN, STIFFNESS AND SORENESS; DIFFICULTY SPEAKING, SWALLOWING AND BREATHING; SWELLING IN HIS NECK AND HANDS; AND RADICULOPATHY IN BOTH LEGS, FEET AND IN HIS LEFT ARM. PATIENT REQUIRED USE OF CRUTCHES OR A CANE TO ASSIST WITH AMBULATION. THESE SERIOUS INJURIES PREVENT THE PATIENT FROM PRACTICING AND ENJOYING THE ACTIVITIES OF DAILY LIFE THAT PATIENT ENJOYED PRE-OPERATIVELY, AND HAD OTHERWISE SUFFERED SERIOUS AND PERMANENT INJURIES.

  Patient problems: Ambulation or Postural Difficulties; Dysphagia/ Odynophagia; Dysphasia; Dyspnea; Neck Pain; Neck Stiffness; Neuropathy; Pain; Swelling

  MAUDE report 7147212 ↗
• InjuryDec 15, 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 ON (B)(6) 2012. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Injury

  MAUDE report 7122513 ↗
• InjuryOct 17, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2010, PATIENT UNDERWENT SPINE FUSION SURGERY ON THE LUMBAR REGIONS AT LEVELS L4-S1. THE PATIENT WAS IMPLANTED WITH RHBMP-2 COLLAGEN SPONGE. THE RHBMP-2 COLLAGEN SPONGE WAS USED TO FUSE MORE THAN ONE LEVEL OF THE SPINE. POST-OP, THE PATIENT COMPLAINED OF PROGRESSIVELY WORSENING LOW BACK PAIN WITH RADICULOPATHY INTO HIS BUTTOCKS AND LOWER EXTREMITIES. PATIENT STILL CONTINUES TO EXPERIENCE CHRONIC LOW BACK PAIN WITH STABBING AND BURNING PAIN RADIATING DOWN BOTH LEGS TO HIS TOES. HE EXPERIENCES DIFFICULTY SITTING, STANDING AND WALKING. PATIENT INJURIES PREVENT HIM FROM PRACTICING DAILY LIFE ACTIVITIES AND REPORTEDLY THE PATIENT HAS SUFFERED SERIOUS AND PERMANENT INJURIES.

  Patient problems: Ambulation or Postural Difficulties; Neuropathy; Pain

  MAUDE report 6953969 ↗
• InjuryOct 17, 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. PATIENT TOLERATED THE PROCEDURE WELL WITHOUT ANY INTRAOPERATIVE COMPLICATIONS. POST-OP, THE PATIENT ALLEGED UNSPECIFIED INJURY DUE TO USE OF RHBMP-2. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED

  Patient problems: Injury

  MAUDE report 6953913 ↗
• InjuryOct 16, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON: (B)(6) 2005 ¿ PT. UNDERWENT SURGERY TO TREAT DEGENERATIVE DISK DISEASE, L5-S1, DISK SPACE WITH LEFT-SIDED COLLAPSE AND ASSOCIATED LEFT L5 NEURAL FORAMINAL STENOSIS AND RADICULOPATHY, SPINAL INSTABILITY, L5-S1, SPONDYLOLYSIS, L3 WITH SPINAL INSTABILITY ,L3-4, AND BILATERAL L3 NEURAL FORAMINAL STENOSIS. PROCEDURE WAS FOR LS-S1 POSTERIOR SPINAL DECOMPRESSION, LEFT, WITH LEFT L5 FORAMINOTOMY, L3-4 POSTERIOR SPINAL DECOMPRESSION, BILATERAL, WITH MEDIAL FACETECTOMIES AND FORAMINOTOMIES, L5-S1 AND L3-4 POSTERIOR LUMBAR INTERBODY FUSION, IMPLANTATION OF RAY CAGES, A SINGLE IMPLANT, L3-4, AND SINGLE IMPLANT, L5-S1, USE OF BONE MORPHOGENIC PROTEIN/BMP, L3-4 AND L5-S1 POSTEROLATERAL SPINAL FUSION, USE OF LOCAL BONE GRAFT/MORSELIZED BONE GRAFT, PEDICLE SCREW INSTRUMENTATION/NON-SEGMENTAL INSTRUMENTATION, L3-4 AND L5-S1, USING 2 SEPARATE CONSTRUCTS, USING THE XIA SYSTEM AT BOTH LEVELS. BMP SOAKED SPONGES WERE PLACED INSIDE THE RAY CAGES. LOCAL BONE AND ALLOGRAFT WAS PLACED IN THE LATERAL GUTTERS. ON (B)(6) 2005 ¿ PT. FOLLOW-UP VISIT. ¿HE REPORTS TODAY THAT THE LEFT LEG PAIN HE HAD IS COMPLETELY RESOLVED. HE STILL HAS SOME BACK PAIN AND COMPLAINS OF SOME LOWER EXTREMITY

  Patient problems: Injury; Pain

  MAUDE report 6950699 ↗
• InjuryOct 10, 2017Adverse 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 RHBMP2/ACS ON L3-L5 IN AN UNSPECIFIED SPINAL FUSION SURGERY. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: Injury

  MAUDE report 6933676 ↗

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-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-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-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-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-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
• 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