INFUSE Bone GraftRecalls & reported problems across all models

We found 6 models of INFUSE Bone Graft by Medtronic Sofamor Danek, Inc. in the FDA's device registry (GUDID). Together they are named in 576 adverse event reports in the FDA's MAUDE database, received between Nov 16, 2016 and Sep 18, 2026 — classified as 571 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Osseointegration Problem” (6 reports).

1 FDA recall record name at least one of these models by its device identifier.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

INFUSE Bone Graft recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Sep 27, 2018Terminated

   The Extra Small INFUSE Bone Graft kit from lot M111806AAA, may contain two absorbable collagen sponges (ACS), but should only contain one ACS.

   Z-0440-2019 · Root cause: Error in labeling · Recall details · FDA record ↗

Most reported INFUSE Bone Graft problems

INFUSE Bone Graft models

6 models, most reported first. Each model has its own page with its reports, recalls and device details.

• INFUSE® Bone Graft 7510800

  Filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction
  180 reports
• INFUSE® Bone Graft 7510200

  FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH METAL PROSTHESIS, OSTEOINDUCTION
  143 reports
• INFUSE® Bone Graft 7510400

  FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH METAL PROSTHESIS, OSTEOINDUCTION
  132 reports
• INFUSE® Bone Graft 7510100

  Bone grafting material, dental, with biologic component
  1 recall23 reports
• INFUSE® Bone Graft 7510600

  Bone grafting material, dental, with biologic component
  69 reports
• INFUSE® Bone Graft 7510050

  Bone grafting material, dental, with biologic component
  29 reports

Recent INFUSE Bone Graft adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjurySep 18, 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: MDT22045C STAIL It was reported that the patient had 3/5 Foot Drop, Right Foot. Interventions: NA Outcome Status: Not Recovered/ Not Resolved On August 20, 2026, a neurological exam was performed and showed right foot drop with 3/5 strength and numbness in the right shin, both of which were considered clinically significant. Site Seriousness Assessment: NA Sponsor Assessment (OC MUO): Sponsor assessed as possible related to index procedure and possible related to device. Update Received on 16-Sep-2026: Site Related Assessment: assessed as not related to study device.

  Patient problems: Peripheral Nervous Injury

  MAUDE report 50813821 ↗
• 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 ↗
• InjuryOct 27, 2025Off-Label Use; Off-Label Use

  2025 NOV 7, UPDATE RECEIVED, ONSET DATE, OUTCOME, OUTCOME DATE FOR THE EVENT OF CHRONIC PAIN IN NECK/ARM. ONSET DATE: 11/2014 OUTCOME: REPEAT SURGERY OUTCOME DATE: (B)(6) 2015, ONSET DATE, OUTCOME, OUTCOME DATE, SEVERITY FOR THE EVENTS OF NUMBNESS IN RIGHT HAND, NUMBNESS IN RIGHT THUMB, POINTER AND MIDDLE FINGER AND FORAMINAL STENOSIS. ONSET DATE: 11/2014 OUTCOME: REPEAT SURGERY OUTCOME DATE: (B)(6) 2015.

  Patient problems: Extraskeletal ossification; Numbness; Pain; Stenosis

  MAUDE report 23389043 ↗
• InjuryOct 22, 2025Off-Label Use; Off-Label Use

  INFORMATION WAS RECEIVED FROM CONSUMER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT THE PATIENT EXPERIENCING CHRONIC PAIN AND REQUIRING ADDITIONAL SURGERY DUE TO ECTOPIC BONE GROWTH FOLLOWING THE IMPLANTATION OF MEDTRONIC INFUSE BONE GRAFT IN THE CERVICAL SPINE DURING SURGERY PERFORMED ON JULY 14, 2015. THE PATIENT WAS NOT NOTIFIED OF KNOWN RISKS, FDA WARNINGS, OR LEGAL ACTIONS RELATED TO THE OFF-LABEL USE OF INFUSE IN THE CERVICAL REGION, AND ONLY RECENTLY BECAME AWARE OF THESE ISSUES AFTER ONGOING HEALTH COMPLICATIONS. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED THAT THE INFUSE WAS USED ON (B)(6) 2014 AT C5/6. THE ADDITIONAL SURGERY TO REMOVE ECTOPIC BONE GROWTH WAS (B)(6) 2015. BOTH SURGERIES WERE DONE AT CEDARS SINAI BY ELI BARON. THE DECISION TO USE INFUSE IN NECK WAS MADE BY SURGEON.

  Patient problems: Extraskeletal ossification; Pain

  MAUDE report 23357950 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionJun 14, 2024Osseointegration Problem; Osseointegration Problem

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER, CLINICAL STUDY) REGARDING A PATIENT WITH CLINICAL ID (B)(6) AND CLINICAL STUDY NAME ALLIANCE IMPLANTED WITH INFUSE HAVING SPINAL FUSION THERAPY. IT WAS REPORTED DURING 6 MONTH VISIT THAT THERE WAS 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 FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION RECEIVED THAT NO HOSPITALIZATION OR ADDITIONAL SURGERY WERE REPORTED FOR THE PATIENT.

  Patient problems: Inadequate Osseointegration

  MAUDE report 19535674 ↗
• 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 ↗
• MalfunctionMar 19, 2024Use of Device Problem; Use of Device Problem

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, RISK MANAGER) REGARDING A PATIENT WHO WAS IMPLANTED WITH INFUSE. IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH AN EXPIRED INFUSE PRODUCT. DATE OF SURGERY WAS (B)(6) 2024. OPERATION PERFORMED WAS C1-2-3-4 POSTERIOR ARTHRODESIS AND BMP WAS PLACED AT C12. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18928533 ↗
• 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 ↗
• InjuryOct 13, 2022Break; Loose or Intermittent Connection

  (B)(6) 2019: DISCOVER MEDTRONIC TITANIUM PEDICLE SCREW AT L4, SCREW HEAD BROKE OFF AND SCREW HEAD LODGED INTO MUSCLE. TWO DIFFERENT NEUROSURGEONS CALL IT PSEUDARTHROSIS OR FAILED BACK SURGERY. (B)(6) 2022: DISCOVER ON MY OWN FDA RECALL REF 7510050. WHAT IS THE REASON FOR WHY NO ONE WOULD CONTACT ME ABOUT THE RECALL? (B)(6) 2022: REVISION SURGERY RESCHEDULED UNTIL CT SCAN COMPLETED. (CT SCAN COMPLETED ON (B)(6) 2022). (B)(6) 2022: APPOINTMENT WITH DR. (B)(6) NEUROSURGEON A REVIEW OF MRI AND CT SCAN IMAGES; DR. (B)(6) SAID THERE IS VERY LITTLE BONE GROWTH ON THE LEFT SIDE FROM L4 DOWN TO S1, THAT'S NOT GOOD. MRI SHOWS PRESSURE BETWEEN L3-L4 ON THE RIGHT SIDE. CT SCAN SHOWS DISLODGED BONE OR BONE-SPUR GROWTH AT L4 CAUSING PRESSURE ON THE NERVES ON THE LEFT SIDE. REVISION SURGERY SCHEDULED FOR (B)(6) 2022. PLEASE SEE OTHER RELEVANT HISTORY FOR DETAILED EXPLANATION. I HAVE SUPPORTING DOCUMENTS AND MRI, CT, AND X-RAY IMAGES ON DISC. OTHER RELEVANT HISTORY: (B)(6) 2017: I MET WITH (B)(6), M.D. TO REVIEW MRI AND DISCUSS SURGERY OPTION. I CHOOSE DR. (B)(6) FOR HIS MINIMAL INVASIVE APPROACH AND 1.5 HOURS IN SURGERY. I HAD SEEN DR. (B)(6) FOR THIS SURGERY AND HIS TIME UNDER THE KNIFE WAS 6 HO

  Patient problems: Anxiety; Chest Pain; Concussion; Dizziness; Foreign Body In Patient; Ischemia Stroke; Malunion of Bone; Sleep Dysfunction

  MAUDE report 15606103 ↗
• InjuryOct 3, 2022Break; Entrapment of Device; Nonstandard Device

  MAJOR LIFE CHANGING EVENT STARTED AFTER 2 STAGE SPINAL FUSION ((B)(6) 2017). (B)(6) 2019: DISCOVER MEDTRONIC TITANIUM PEDICLE SCREW AT L4, SCREW HEAD BROKE OFF AND SCREW HEAD LODGED INTO MUSCLE. TWO DIFFERENT NEUROSURGEONS CALL IT PSEUDARTHROSIS OR FAILED BACK SURGERY. (B)(6) 2022: DISCOVER ON MY OWN FDA RECALL REF 7510050. WHAT IS THE REASON FOR WHY NO ONE WOULD CONTACT ME ABOUT THE RECALL? (B)(6) 2022: REVISION SURGERY RESCHEDULED UNTIL CT SCAN COMPLETED. (CT SCAN COMPLETED ON (B)(6) 2022). (B)(6) 2022: OFFICE VISIT WITH DR (B)(6) TO REVIEW ALL IMAGES, DEVELOPE SURGERY PLAN, AND SCHEDULE REVISION SURGERY. PLEASE SEE OTHER RELEVANT HISTORY FOR DETAILED EXPLANATION.

  Patient problems: Device Embedded In Tissue or Plaque; Failure of Implant

  MAUDE report 15537063 ↗

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