INFUSE® Bone Graft 7510400Recalls & reported problems

Summary

The FDA's MAUDE database contains 132 adverse event reports that list this exact device (DI 00681490843805), received between Nov 16, 2016 and May 27, 2026 — classified as 129 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Osseointegration Problem” (3 reports).

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 132 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 27, 2026Osseointegration Problem

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER, CLINICAL STUDY) REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT, DURING A 12-MONTH STUDY FOLLOW-UP ASSESSMENT, THE SURGEON ASSESSED FUSION STATUS AT ALL TREATED SPINAL LEVELS AND NOTED THAT SOME FUSION WAS SEEN BUT FUSION HAD NOT FULLY OCCURRED AT ALL TREATED LEVELS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED THAT THERE WAS NO CONFIRMED DEVICE ALLEGATION, THIS WAS A REPORTED CLINICAL FINDING WHICH MAY BE CONSIDERED NORMAL FOR THE CLINICAL CASE. SAFETY HAS REQUESTED ADDITIONAL INFORMATION THAT WILL BE PROVIDED IF THE INVESTIGATOR DETERMINES AN ABNORMAL FINDING HAS OCCURRED.

  Patient problems: Inadequate Osseointegration

  MAUDE report 25296528 ↗
• InjuryMar 24, 2026Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER, CLINICAL STUDY) REGARDING A PATIENT WITH CLINICAL ID (B)(6) AND STUDY ID (B)(6) STAIL DEVICE USED FOR POSTERIOR FIXATION FUSION PROCEDURE. IT WAS REPORTED THAT PATIENT HAD PSEUDARTHROSIS. INTERVENTIONS: ACTION SUBTYPE: HOSPITILIZATION ACTION RESULT: NEW HOSPITILIZATION ACTION DATE: (B)(6) 2025 ACTION SUBTYPE: AE RESULT IN ANY TREATMENT \ACTION RESULT: YES ACTION SUBTYPE: MEDICATION ADMINISTRATION ACTION RESULT: YES ANY OF THESE OPIATES OR NARCOTICS (ADJUSTED OR ADMINISTRED) YES ACTION SUBTYPE: SPINAL SURGERY ACTION RESULT: YES SPECIFY THE ADDITIONAL SPINAL SURGERY ADDITIONAL SPINAL SURGERY, (B)(6) 2025 MEDICATION_NAME: FENTANYL START_DATE: (B)(6) 2025 DOSE: 25 DOSE UOM: UG FREQUENCY: PRN: AS NEEDED ROUTE: INTRAVENOUS REASON STARTED/INDICATION: PAIN END_DATE: (B)(6) 2025 CORRESPONDING AE 001_(B)(6) 2025_PSEUDARTHROSIS MEDICATION_NAME: HYDROMORPHONE START_DATE: (B)(6) 2025 DOSE: 0.5 DOSE UOM: MG FREQUENCY: PRN: AS NEEDED ROUTE: INTRAVENOUS REASON STARTED/INDICATION: PAIN END_DATE: (B)(6) 2025 CORRESPONDING AE 001_(B)(6) 2025_PSEUDARTHROSIS MEDICATION_NAME: MORPHINE ER START_DATE: (B)(6)

  Patient problems: Back pain; Neuropathy

  MAUDE report 24672316 ↗
• MalfunctionOct 21, 2025Osseointegration Problem; Osseointegration Problem

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER, CLINICAL STUDY) REGARDING A PATIENT WITH CLINICAL ID: (B)(6), STUDY ID: (B)(6) (AILLIANCE). IT WAS REPORTED THAT DURING THE 12-MONTH SUBJECT VISIT, IT WAS NOTED THAT THE FUSION HAS NOT FULLY OCCURRED. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Inadequate Osseointegration

  MAUDE report 23345692 ↗
• InjuryApr 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACTION TAKEN: MEDICATIONS: YES WERE ANY OF THESE OPIATES OR NARCOTICS (ADJUSTED OR ADMINISTERED): YES HYDROCODONE/APAP 10/325 KETAMINE METHADONE HYDROMORPHONE OXYCODONE HYDROCODONE- APAP 7.5-325 MG TABLET OXYCODONE- APAP 10-325 MG TABLET KETAMINE METHADONE FENTANYL HYDROMORPHONE MORPHINE ER AE1 UPDATE: HOSPITALIZATION DETAILS PROVIDED, ASSESSED AS SAE BY SITE AND SPONSOR, ADD SPINE SURG (1) REPORTED DID THE AE RESULT IN THE SUBJECT BEING HOSPITALIZED OR A PROLONGATION OF AN EXISTING HOSPITALIZATION - NEW HOSPITALIZATION WHAT IS THE START DATE OF THE HOSPITALIZATION- (B)(6) 2025 WHAT IS THE END DATE OF THE HOSPITALIZATION- (B)(6) 2025 DID THE AE RESULT IN ANY TREATMENT- YES; AE SERIOUS FLAG- YES DATE OF ADDITIONAL SPINAL SURGERY- (B)(6) 2025 WHAT WAS THE PRIMARY REASON FOR THE ADDITIONAL SPINAL SURGERY- ADVERSE EVENT RELATED TO STUDYINDEX SURGERY IF AE, SPECIFY THE CORRESPONDING AE - 001_4 APR 2025_PSEUDARTHROSIS REVISION SPINAL LEVELS: L5, S1

  Patient problems: Back pain; Nonunion/Delayed-union Bone Fracture

  MAUDE report 21863328 ↗
• MalfunctionJun 14, 2024Osseointegration Problem; Osseointegration Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER, CLINICAL STUDY VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT, PROBABLE SIGNIFICANT RESORPTION OF THE BONE GRAFT DUE TO PSEUDOARTHROSIS, MAJOR LUCENCY, OR GAP VISIBLE IN FUSION AREA (2MM AROUND THE ENTIRE PERIPHERY OF GRAFT). THERE WERE NO ASSESSMENTS MADE BY SPONSOR AND INVESTIGATOR. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Inadequate Osseointegration

  MAUDE report 19535611 ↗
• InjurySep 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A DISTRIBUTOR VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH SPINAL INSTABILITY FOR SPINAL FIXATION THERAPY. IT WAS REPORTED THAT THE PATIENT HAS INFECTIOUS CELLULITIS FROM INFUSION USE. THERE WAS A TEMPORARY INJURY AS A RESULT OF THE EVENT. THE PART REMAIN IMPLANTED AND IN SERVICE. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Cellulitis

  MAUDE report 10542190 ↗
• InjuryApr 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT ALLEGED SUFFERED FROM HETERO TOPIC OSSIFICATION, FLAT BACK SYNDROME (LOSS OF CURVATURE IN BACK SURGERY), CHRONIC REG. PAIN SYNDROME, CAUDA EQUINA SYND. (COMPLETE LOSS OF BLADDER, SEVERE WEAKNESS IN LEGS), ARACHNOIDITIS(ELECTRIC SHOCKING OF LOWER BACK AN LEGS), PARALYSIS (ON LEFT SIDE OF VAGINAL AREA AND THIGH). 01 AUG 2014: THE PATIENT PRESENTED WITH THE FOLLOWING PRE-OPERATIVE DIAGNOSIS: 1) L3-4 AND L4-5 SPONDYLOLISTHESIS. 2) BILATERAL LUMBAR RADICULOPATHY AND SEVERE FORAMINAL STENOSIS. 3) DIFFUSE IDIOPATHIC SKELETAL ¿HYPEROSMOSIS¿ WITH POSTERIOR CALCIFICATION OF LIGAMENTUM FLAVUM DIFFUSELY THROUGH THE LUMBAR SPINE. 4) SEVERE CENTRAL AND LATERAL RECESS STENOSIS. 5) MORBID OBESITY, BODY MASS INDEX OF 50. SHE UNDERWENT THE FOLLOWING PROCEDURES: 1) SEGMENTAL INSTRUMENTATION, L2 TO ILIAC USINGSCREW AND ROD SYSTEMS INCLUDING ILIAC SCREWS. 2) L2 TO SACRUM POSTERIOR LATERAL ARTHRODESIS WITH USE OF AUTOGRAFT, 30ML OF GRAFTON, BMP MEDIUM INFUSE, 15ML OF CRUSHED CANCELLOUS. 3) L3 TO SACRUM LAMINECTOMIES. 4) RIGHT L3-4 TRANSFORAMINAL INTERBODY FUSION WITH PLACEMENT OF INTERBODY CAGE. 5) LEFT 4-5 TRANSFORAMINAL INTERBODY FUSION WITH PLACEMENT OF INTERBODY CAGE. 6) BILATERAL OSTEOT

  Patient problems: Ambulation or Postural Difficulties; Arachnoiditis, Spinal; Extraskeletal ossification; Pain; Paralysis

  MAUDE report 8523867 ↗
• InjuryOct 19, 2018Adverse 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 THE FOLLOWING PRE-OP DIAGNOSIS: SPINAL STENOSIS. DISK HERNIATION WITH SPONDYLOLISTHESIS. SHE UNDERWENT THE FOLLOWING PROCEDURES: L2-3, L3-4, L4-5 AND L5-S1 DECOMPRESSIVE LAMINECTOMY WITH L4-5 DISKECTOMY. INTERBODY FUSION UTILIZING PEEK IMPLANTS WITH L2-S1 PEDICLE SCREW FIXATION. POSTEROLATERAL FUSION. AS PER THE OPERATIVE NOTES, ¿WE PREPARED THE DISK FOR THE INTERBODY FUSION. WE ENDED UP PLACING A 15MM PEEK GRAFT PACKED WITH BMP AND PATIENT BONE. THIS WAS COUNTERSUNK WITH GOOD FIXATION AND FUSION. WE PLACED ONE GRAFT BILATERALLY. WE THEN PLACED THESE INTO COMPRESSION AND TIGHTENED THE NUTS ACROSS THE RODS WHICH WERE PLACED ACROSS THE L2, L3, L4, L5 AND S1 SCREWS. WE OBTAINED AN X-RAY CONFIRMING GOOD PLACEMENT OF THE SCREWS AND RODS AS WELL AS THE INTERBODY FUSION. WE DECORTICATED POSTEROLATERALLY AND DID A FUSION AT L2-3, L3-4, L4-5 AND L5-S1. WE DID THIS WITH BMP, DEMINERALIZED BONE MATRIX MIXED WITH PATIENT¿S BONE AS WELL AS PUTTY." NO INTRA-OPERATIVE COMPLICATIONS WERE REPORTED. POST-OPERATIVELY, THE PATIENT ALLEGED UNSPECIFIED INJURY DUE TO THE USE OF RHBMP-2/ACS.

  Patient problems: Injury

  MAUDE report 7983200 ↗
• InjuryOct 17, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT PRESENTED WITH THE FOLLOWING PRE-OP DIAGNOSIS: SEVERE DEGENERATIVE SPONDYLOLISTHESIS L4-5 WITH FORAMINAL STENOSIS BILATERALLY AT L4-5 AND SCIATIC PAIN LEFT SIDES, DEGENERATIVE SPONDYLOLISTHESIS, SCIATIC PAIN, DEGENERATIVE DISK DISEASE. SHE UNDERWENT THE FOLLOWING PROCEDURES: POSTERIOR LUMBAR FUSION AT L4-5 AND POSTERIOR LUMBAR INTERBODY FUSION AT L4-5, DECOMPRESSIVE LAMINOTOMY AND FORAMINOTOMY BILATERALLY, AUTOLOGOUS BONE GRAFT HARVESTING, NON SEGMENTAL INSTRUMENTATION L4-5 WITH PEDICLE SCREW FIXATION., INSERTION OF BIOMECHANICAL DEVICE, POSTERIOR LUMBAR INTERBODY FUSION CAGE AT L4-5 FROM THE LEFT SIDE,USE OF MICROSCOPE FOR THE DECOMPRESSIVE PROCEDURE, PLATELET TISSUE GRAFT MATERIAL FOR FUSION AND CLOSURE. AS PER THE OPERATIVE NOTES: SIZING WAS CARRIED OUT AND AN 11 MM HIGH CAGE WAS DECIDED UPON. X-RAY WITH THE 12-GAUGE IN PLACE DID SHOW SOME SLIGHTLY OVER DISTRACTION ON THE LEFT SIDE. THE 11 MM POSTERIOR LUMBAR INTERBODY FUSION CAGE WAS OBTAINED. BONE MORPHOGENIC PROTEIN WAS OBTAINED AND THE CAGE WAS PACKED WITH BONE MORPHOGENIC PROTEIN. DECORTICATION OF THE ENDPLATES WAS CARRIED OUT USING A BUR BILATERALLY AND THE AUTOLOGOUS BONE WHICH WAS MIXED WITH THE BONE GEL AND

  Patient problems: Injury

  MAUDE report 7976413 ↗
• InjuryOct 15, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT PRESENTED WITH THE FOLLOWING PRE-OP DIAGNOSIS: LUMBAR DISKOGENIC BACK PAIN, L3-L4, L4-L5. PATIENT UNDERWENT THE FOLLOWING PROCEDURES: ANTERIOR INTERBODY FUSION, L3-L4 AND L4-L5 WITH ALLOGRAFT AND RHBMP-2. AS PER THE OPERATIVE NOTES, ¿GRAFT WAS CUT WITH OSCILLATING SAW ON THE BACK TABLE. RHBMP-2 WAS PACKED INTO THE MEDULLARY CANAL AND ALLOGRAFT TAPPED INTO PLACE.¿ NO INTRA-OPERATIVE COMPLAIN WERE REPORTED. POST-OP, PATIENT SUFFERED WITH UNSPECIFIED INJURIES AFTER THE SURGERY.

  Patient problems: Injury

  MAUDE report 7967724 ↗
• InjurySep 11, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED IN A POST-MARKET STUDY THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH STENOSIS WITH INSTABILITY AND UNDERWENT POSTERIOR LUMBAR FUSION (PLF) SURGERY AT L2-S1 LEVELS. POST-OPERATIVELY, THE PATIENT COMPLAINED OF LOW BACK PAIN. THE ADVERSE EVENT (AE) WAS CONCLUDED AS BEING NON-SERIOUS.

  Patient problems: Pain

  MAUDE report 7863237 ↗
• InjuryJul 25, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON UNKNOWN DATE, THE PATIENT UNDERWENT MRI SHOWS EVIDENCE OF A DEGENERATIVE LUMBAR SCOLIOSIS. HE HAS ABOUT AN 18 DEGREE CURVE MEASURED FROM 1 DOWN TO L5. HE HAS DEGENERATIVE DISK DISEASE WITH DISC DEHYDRATION AND LOSS OF DISK HEIGHT AT L1-2, L2-3, L3-4, L4-5 AND L5-S1. HE HAS SIGNIFICANT STENOSIS AT L2-3, L3-4 AND L4-5. HE HAS FORAMINAL NARROWING AT MULTIPLE LEVELS BUT MAINLY ON THE RIGHT SIDE. IMPRESSION: FROM A CLINICAL POINT OF VIEW, HIS PAIN SEEMS TO RADIATE INTO AN L4 NERVE ROOT DISTRIBUTION. THE WEAKNESS IN HIS TIBIAL ANTERIOR MAY HAVE AN L4 COMPONENT TO IT BUT THERE ALSO MAY BE AN L5 COMPONENT TO IT. HOWEVER, HIS PAIN REALLY DOES NOT RADIATE IN THE L5 DISTRIBUTION. (B)(6) 2011: THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH: L2-3, L3-4, L4-5 CENTRAL SPINAL STENOSIS. LEFT L5-S1 LATERAL RECESS AND FORAMINAL STENOSIS. LUMBAR DEGENERATIVE SCOLIOSIS AND UNDERWENT. L2,L3 ,L4 AND L5 COMPLETE LAMINECTOMIES WITH BILATERAL S1 SUPERIOR LAMINECTOMIES. LEFT L4-5 AND L5-S1 MEDIAL FACETECTOMIES PERFORMED UTILIZING THE OPERATING MICROSCOPE AND MICRODISSECTION TECHNIQUE. OPEN REDUCTION OF DEGENERATIVE LUMBAR SCOLIOSIS. L2 THROUGH S1 POSTEROLATERAL ONLAY FUSION UTILIZING

  Patient problems: Edema; Injury; Seroma

  MAUDE report 7717657 ↗
• InjuryJul 4, 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: L5-S1 ADVANCED DEGENERATIVE DISK DISEASE. DISK HERNIATION AND STENOSIS. THE PATIENT UNDERWENT FOLLOWING PROCEDURES: BILATERAL L5 HEMILAMINECTOMY AND FORAMINOTOMY. L5-S1 DISKECTOMY. TRANSFORAMINAL LUMBAR INTERBODY FUSION. L5-S1 ST360 PEDICLE SCREW FIXATION. L5-S1 LATERAL MASS FUSION. RHBMP-2. 7. CELL SAVER. AS PER OPERATIVE NOTES , "THE SCREWS WERE CONNECTED BY TITANIUM ROD AND 10 NM T-BOLTS. ALL ATTACHMENTS WERE SECURED. LOCAL AUTOLOGOUS BONE WITH DENUDED SOFT TISSUE WAS MORSELIZED AND USED AS A FILLING FOR RHBMP2-SOAKED SPONGES WHICH WERE LAID OVERLYING THE LATERAL MASSES AND TRANSVERSE PROCESSES AT L5-S1 BILATERALLY¿. NO INTRA-OPERATIVE COMPLICATIONS WERE REPORTED. NO OTHER INFO WAS AVAILABLE.

  Patient problems: Injury

  MAUDE report 7662202 ↗
• InjuryJul 4, 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 PRESENTED WITH C3 THROUGH C6 STENOSIS WITH CORD COMPRESSION AND MYELOPATHY. THE PATIENT UNDERWENT THE FOLLOWING PROCEDURES: C3 THROUGH C6 BILATERAL DECOMPRESSIVE LAMINECTOMY AND FUSION WITH LATERAL MASS SCREWS AND RIGHT-SIDED C5-6 FORAMINOTOMY. AS PER THE OPERATIVE NOTES,¿ THE BONE OBTAINED WAS CAREFULLY MORCELLATED AND FREED FROM SOFT TISSUE IN ORDER TO USE IT FOR THE SUBSEQUENT FUSION. WITH ADEQUATE DECOMPRESSION OF THE SPINAL CORD, ATTENTION WAS TURNED TOWARDS FORAMINOTOMY OF C5-6 ON THE RIGHT SIDE. SOFT TISSUE BLEEDING WAS CONTROLLED WITH BIPOLAR CAUTERY AND ONCE THIS WAS SATISFACTORY THE ENTIRE SURGICAL SITE WAS IRRIGATED WITH WARM SALINE. BONE GRAFT AND RHBMP2/ACS WAS PLACED ALONG THE LATERAL GUTTERS IN CONTACT WITH BONE, WHICH HAD BEEN PREVIOUSLY BEEN DECORTICATED WITH A SMALL BURR. ALL RETRACTORS WERE THEN REMOVED ALLOWING TISSUES TO COME BACK TOGETHER.¿ NO INTRA-OPERATIVE COMPLICATIONS WERE REPORTED.

  Patient problems: Injury

  MAUDE report 7661821 ↗
• InjuryJul 3, 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 PRESENTED WITH THE FOLLOWING PRE-OP DIAGNOSIS: L4-5 HIGH GRADE STENOSIS AND CENTRAL DISC PROTRUSION. THE PATIENT UNDERWENT THE FOLLOWING PROCEDURES: BILATERAL L4 DECOMPRESSION, L4-5 DISCECTOMY, PEDICLE SCREW FIXATION, L4-5 LATERAL MASS FUSION, REMOVAL OF OLD HARDWARE, L5-S1 LEVEL. AS PER THE OPERATIVE NOTES, ¿LOCAL AUTOLOGOUS BONE WITH MORSELIZED DENUDED SOFT TISSUE WAS USED AS A FILLING, BMP(BONE MORPHOGENIC P ROTEIN)-SOAKED SPONGES WERE LAID OVER LATERAL MASS, TRANSVERSE PROCESSES OF L4-5 BILATERALLY.¿ NO INTRA-OPERATIVE COMPLICATIONS WERE REPORTED.

  Patient problems: Injury

  MAUDE report 7657692 ↗
• InjuryJun 19, 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 7614817 ↗
• 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 7595209 ↗
• InjuryJun 12, 2018Adverse 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 WAS ADMITTED AND THE PATIENT UNDERWENT A FUSION SURGERY IN WHICH RHBMP-2/ACS WAS USED. THE PATIENT WAS DISCHARGED ON (B)(6) 2009. NO INTRA-OPERATIVE COMPLICATIONS WERE REPORTED.

  Patient problems: Injury

  MAUDE report 7590353 ↗
• InjuryJun 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HYPOAESTHESIA IT WAS REPORTED THAT THE PATIENT HAD UNDERWENT UNSPECIFIED SURGERY INVOLVING RHBMP-2. POST-OP, PATIENT REPORTEDLY HAD RIGHT LOWER EXTREMITY NUMBNESS-INTERMITTENT NUMBNESS RADIATING FROM LATERAL THIGH INTO FOOT. OUTCOME : NOT RECOVERED/NOT RESOLVED.

  Patient problems: Numbness

  MAUDE report 7571962 ↗
• InjuryMay 17, 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 PRESENTED WITH THE FOLLOWING PRE-OP DIAGNOSIS: L3-4 AND L4-5 DISC PROTRUSION WITH ANNULAR TEARS AND UNDERWENT THE FOLLOWING PROCEDURES: L3-4 AND L4-5 ANTERIOR LUMBAR INTERBODY FUSION VIA DIRECT LATERAL APPROACH, ENDOSCOPICALLY ASSISTED. PLACEMENT OF CARBON FIBER FUSION CAGES AT L3-4, L4-5. PLACEMENT OF BONE MORPHOGENIC PROTEIN(BMP). AS PER OPERATIVE NOTES,¿ THE ANNULOTOMY, DISCECTOMY ,ENDPLATE PREPARATION WAS DONE, SHAPING AND FITTING OF THE DISC SPACE TO A SIZE 10 NON-LORDOSED (PARALLEL) 55 MM CAGE WAS DONE AND PLACED AT L3-4 THAT WAS PREFILLED WITH THE BMP AND WAS SECURED WITH ABSORBABLE 2-0 VICRYL SUTURE. SIMILARLY, PROCEDURE WAS PERFORMED AT L4-5. X-RAYS REVEALED QUITE GOOD CAGE PLACEMENT AT BOTH LEVELS." NO INTRA-OPERATIVE COMPLICATIONS WERE REPORTED. POST-OP, THE PATIENT COMPLAINED OF INCREASINGLY SEVERE PAIN IN HIS LOW BACK WITH RADICULOPATHY, WEAKNESS, NUMBNESS, TINGLING AND BURNING INTO HIS LEGS. IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEVERE AND UNRELENTING LOW BACK PAIN AND SWELLING, NUMBNESS AND TINGLING FROM HIS BACK DOWN INTO HIS HIPS AND LEGS, AND BURNING IN HIS CALVES, AS WELL AS DIFFICULTY IN STANDING AND WALKI

  Patient problems: Burning Sensation; Neuropathy; Numbness; Pain; Tingling; Weakness

  MAUDE report 7521222 ↗
• InjuryMay 11, 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 LUMBAR SPINE IN WHICH RHBMP-2/ACS WAS USED.

  Patient problems: Injury

  MAUDE report 7506787 ↗
• InjuryMay 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 MULTILEVEL SPINAL STENOSIS AND UNDERWENT THE FOLLOWING PROCEDURES: POSTERIOR SPINAL FUSION L3-5. POSTERIOR SPINAL INSTRUMENTATION, L3 TO L5. LEFT ILIAC CREST BONE GRAFT. AS PER OP-NOTES,¿ WE THEN DECORTICATED THROUGHOUT AND PACKED COPIOUS AMOUNTS OF BONE GRAFT AND BMP IN THE POSTERIOR LATERAL GUTTERS AND INTO THE FACETS.¿ THE PATIENT TOLERATED THE PROCEDURE WELL WITHOUT ANY INTRAOPERATIVE COMPLICATIONS.

  Patient problems: Injury

  MAUDE report 7500142 ↗
• InjuryMar 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 IN WHICH RHBMP2/ACS WAS USED.

  Patient problems: Injury

  MAUDE report 7327881 ↗
• InjuryMar 7, 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: GRADE II LYTIC SPONDYLOLISTHESIS AT L5-S1. LEFT L5 RADICULOPATHY. FORAMINAL STENOSIS BILATERALLY AT L5-S1, LEFT SIDE GREATER THAN RIGHT. DEGENERATIVE DISC DISEASE L4-L5 AND L5-S1. RETROLISTHESIS L4-L5. POSTERIOR SPINAL FUSION L4-L5 AND L5-S1. POSTERIOR SEGMENTAL SPINAL INSTRUMENTATION L4, L5, SACRUM, PELVIS, ILIUM BILATERALLY. MIDLINE AND LEFT-SIDED GILL LAMINECTOMY. DECOMPRESSION AT L4, L5 AND S1 ON THE LEFT SIDE WITH DECOMPRESSION OF NERVE ROOT FROM L4 TO THE SACRUM ON THE LEFT SIDE AND THE LEFT L5 NERVE ROOT ON THE LEFT SIDE 5. SOMATOSENSORY AND PERCUTANEOUS MOTOR-EVOKED POTENTIALS, WAKE UP TEST. AS PER OP-NOTES,¿ DECORTICATED L4, L5, S1 TRANSVERSE PROCESSES. PRETTY EASY TO DO THIS ON THE LEFT SIDE. ON THE RIGHT SIDE, QUITE BIT OF STRUGGLE. HAD TO GO AROUND TO THE OTHER SIDE OF THE TABLE. DID THE BEST WE COULD WITH DECORTICATING. THE MUSCLE STRIP WAS NOT QUITE AS WIDE ON THE RIGHT SIDE AS ON THE LEFT SIDE. RETRACTING AND DISSECTING MUSCLES WAS EXTREMELY DIFFICULT. BOTH SIDES DECORTICATED L4, L5, S1 TRANSVERSE PROCESSES. THEN PACKED IN BONE GRAFT STEW WHICH WAS 80 MG BONE MORPHOGENIC PROTEIN, 40 ML SP

  Patient problems: Injury

  MAUDE report 7319732 ↗
• InjuryFeb 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 RHBMP-2/ACS WAS IMPLANTED. ON (B)(6) 2010: THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH SPINAL REOPERATION. SPINAL DISC HERNIATION. SPINAL DISC DEGENERATION. SPINAL STENOSIS. SPINAL INSTABILITY. STATUS POST PREVIOUS LUMBAR LAMINECTOMY L3 TO S1 AND UNDERWENT THE FOLLOWING PROCEDURES: GILL LAMINECTOMY L2-L3, L3-L4, L4-L5, L5-S1. LUMBAR DISCECTOMY, L4-L5, L5-S1. RESECTION OF EPIDURAL SCAR. NEUROLYSIS OF L5 NERVE ROOTS BILATERALLY. CODE 22 REOPERATION. USE OF INTRAOPERATIVE FLUOROSCOPY. FUSION, POSTEROLATERAL L2, L3, L4-L5, AND S1 FUSION, AUTOGRAFT AND BMP. FUSION POSTERIOR LUMBAR INTERBODY L4-L5 AUTOGRAFT. FUSION POSTERIOR LUMBAR INTERBODY L5-S1 AUTOGRAFT, ALLOGRAFT, AND BMP. INSTRUMENTATION MACHINE TOOLED BONE DOWEL, L4-L5 POSTERIOR LUMBAR INTERBODY, MACHINE TOOLED BONE DOWEL L5-S1 POSTERIOR LUMBAR INTERBODY. SCREWS L2, L3, L4-L5, AND S1. PLACEMENT OF EPIDURAL MORPHINE. AS PER OP-NOTES,¿ THE LOCALLY OBTAINED BONE WAS MIXED WITH BMP AND PLACED POSTEROLATERALLY FOR FUSION AT L2, L3, L4, L5 AND S1. THE INTERSPACE WAS DISTRACTED AND VIA THE POSTERIOR LUMBAR INTERBODY ROUTE LARGE VOLUMES OF AUTOGRAFT AND BMP WAS PLACED I

  Patient problems: Injury

  MAUDE report 7277610 ↗

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-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-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-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-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