GRAFTONand GRAFTON PLUSDemineralized Bone Matrix (DBM)Recalls & reported problems across all models

We found 25 models of GRAFTONand GRAFTON PLUSDemineralized Bone Matrix (DBM) by Medtronic Sofamor Danek, Inc. in the FDA's device registry (GUDID). Together they are named in 12 adverse event reports in the FDA's MAUDE database, received between Jan 2, 2017 and Feb 4, 2026 — classified as 9 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Biocompatibility” (1 report).

16 FDA recall records name at least one of these models by its device identifier, 16 still open.

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

GRAFTONand GRAFTON PLUSDemineralized Bone Matrix (DBM) 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. Aug 12, 2026Open, Classified

   Medtronic identified through donor record review that the donor for Medtronic batch A62881 did not meet all Medtronic donor eligibility requirements related to the presence of microbial organisms. While the batch passed finished product sterility testing Medtronic is retrieving any unused product manufactured from the donor tissue. Donor bone tissue tested positive for Clostridium butyricum and while tissue did undergo gamma radiation, if implanted, there is a possibility of clostridium infection.

   Z-0138-2027 · Root cause: Process change control · Recall details · FDA record ↗

2. Aug 12, 2026Open, Classified

   Medtronic identified through donor record review that the donor for Medtronic batch A62881 did not meet all Medtronic donor eligibility requirements related to the presence of microbial organisms. While the batch passed finished product sterility testing Medtronic is retrieving any unused product manufactured from the donor tissue. Donor bone tissue tested positive for Clostridium butyricum and while tissue did undergo gamma radiation, if implanted, there is a possibility of clostridium infection

   Z-0137-2027 · Root cause: Process change control · Recall details · FDA record ↗

3. Sep 26, 2023Class IIOpen, Classified

   Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requirements. Based on this, batches may have been released with potential non-conformances in the outer Tyvek pouch.

   Z-0166-2024 · Root cause: Employee error · names 3 of these models · Recall details · FDA record ↗

4. Sep 26, 2023Class IIOpen, Classified

   Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requirements. Based on this, batches may have been released with potential non-conformances in the outer Tyvek pouch.

   Z-0165-2024 · Root cause: Employee error · names 3 of these models · Recall details · FDA record ↗

5. Sep 26, 2023Class IIOpen, Classified

   Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requirements. Based on this, batches may have been released with potential non-conformances in the outer Tyvek pouch.

   Z-0164-2024 · Root cause: Employee error · names 2 of these models · Recall details · FDA record ↗

6. Sep 26, 2023Class IIOpen, Classified

   Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requirements. Based on this, batches may have been released with potential non-conformances in the outer Tyvek pouch.

   Z-0163-2024 · Root cause: Employee error · names 2 of these models · Recall details · FDA record ↗

7. Sep 26, 2023Class IIOpen, Classified

   Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requirements. Based on this, batches may have been released with potential non-conformances in the outer Tyvek pouch.

   Z-0162-2024 · Root cause: Employee error · Recall details · FDA record ↗

8. Sep 26, 2023Class IIOpen, Classified

   Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requirements. Based on this, batches may have been released with potential non-conformances in the outer Tyvek pouch.

   Z-0161-2024 · Root cause: Employee error · Recall details · FDA record ↗

9. Feb 8, 2023Class IIOpen, Classified

   Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier.

   Z-1333-2023 · Root cause: Process control · names 4 of these models · Recall details · FDA record ↗

10. Feb 8, 2023Class IIOpen, Classified

    Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier.

    Z-1329-2023 · Root cause: Process control · names 3 of these models · Recall details · FDA record ↗

11. Feb 8, 2023Class IIOpen, Classified

    Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier.

    Z-1328-2023 · Root cause: Process control · names 2 of these models · Recall details · FDA record ↗

12. Feb 8, 2023Class IIOpen, Classified

    Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier.

    Z-1327-2023 · Root cause: Process control · names 2 of these models · Recall details · FDA record ↗

13. Feb 8, 2023Class IIOpen, Classified

    Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier.

    Z-1326-2023 · Root cause: Process control · names 4 of these models · Recall details · FDA record ↗

14. Feb 8, 2023Class IIOpen, Classified

    Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier.

    Z-1325-2023 · Root cause: Process control · names 3 of these models · Recall details · FDA record ↗

15. Feb 8, 2023Class IIOpen, Classified

    Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier.

    Z-1324-2023 · Root cause: Process control · names 2 of these models · Recall details · FDA record ↗

16. Feb 8, 2023Class IIOpen, Classified

    Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier.

    Z-1323-2023 · Root cause: Process control · names 5 of these models · Recall details · FDA record ↗

Most reported GRAFTONand GRAFTON PLUSDemineralized Bone Matrix (DBM) problems

GRAFTONand GRAFTON PLUSDemineralized Bone Matrix (DBM) models

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

• GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM) T44150

  FILLER, BONE VOID, CALCIUM COMPOUND
  3 recalls1 report
• GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM) T45005

  Filler, bone void, osteoinduction (w/o human growth factor)
  3 recalls0 reports
• GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM) T45010

  Filler, bone void, osteoinduction (w/o human growth factor)
  2 recalls2 reports
• GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM) T44135

  Filler, bone void, osteoinduction (w/o human growth factor)
  2 recalls1 report
• GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM) T42275

  FILLER, BONE VOID, CALCIUM COMPOUND
  2 recalls1 report
• GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM) T44115

  Filler, bone void, osteoinduction (w/o human growth factor)
  2 recalls1 report
• GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM) T44145

  FILLER, BONE VOID, CALCIUM COMPOUND
  2 recalls0 reports
• GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM) T45001

  Filler, bone void, osteoinduction (w/o human growth factor)
  2 recalls0 reports
• GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM) T42100

  Filler, bone void, osteoinduction (w/o human growth factor)
  2 recalls0 reports
• GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM) T42200

  FILLER, BONE VOID, CALCIUM COMPOUND
  2 recalls0 reports
• GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM) T42210

  Filler, bone void, osteoinduction (w/o human growth factor)
  2 recalls0 reports
• GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM) T42280

  FILLER, BONE VOID, CALCIUM COMPOUND
  2 recalls0 reports
• GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM) T43105

  Filler, bone void, osteoinduction (w/o human growth factor)
  1 recall4 reports
• GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM) T43102

  FILLER, BONE VOID, CALCIUM COMPOUND
  1 recall2 reports
• GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM) T44125

  FILLER, BONE VOID, CALCIUM COMPOUND
  1 recall0 reports
• GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM) T41110

  Filler, bone void, osteoinduction (w/o human growth factor)
  1 recall0 reports
• GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM) T41120

  FILLER, BONE VOID, CALCIUM COMPOUND
  1 recall0 reports
• GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM) T41130

  Filler, bone void, osteoinduction (w/o human growth factor)
  1 recall0 reports
• GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM) T41150

  Filler, bone void, osteoinduction (w/o human growth factor)
  1 recall0 reports
• GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM) T42090

  Filler, bone void, osteoinduction (w/o human growth factor)
  1 recall0 reports
• GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM) T42110

  Filler, bone void, osteoinduction (w/o human growth factor)
  1 recall0 reports
• GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM) T43101

  Filler, bone void, osteoinduction (w/o human growth factor)
  1 recall0 reports
• GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM) T44105

  FILLER, BONE VOID, CALCIUM COMPOUND
  1 recall0 reports
• GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM) T43110

  FILLER, BONE VOID, CALCIUM COMPOUND
  1 recall0 reports
• GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM) T43103

  Filler, bone void, osteoinduction (w/o human growth factor)
  1 recall0 reports

Recent GRAFTONand GRAFTON PLUSDemineralized Bone Matrix (DBM) adverse event reports

The 12 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionFeb 4, 2026

  PT HAVING A MULTI-LEVEL SPINAL FUSION THAT REQUIRED USE OF BONE GRAFT MATERIAL SPECIFICALLY ORTHOBLEND WHICH IS A MEDTRONIC PRODUCT THAT COMES IN 5 AND 10 CC AMOUNTS. FOR THIS CASE DR REQUESTED 30 CC OF ORTHOBLEND. THE BOXES & INSIDE PACKAGES WERE SHOWN TO THE SCRUB TECH PRIOR TO OPENING AND ALL PRODUCT DESCRIPTIONS, AMOUNTS & EXPIRATION DATES WERE VERIFIED BETWEEN THE CIRCULATOR & THE SCRUB. THE ORTHOBLEND WAS PASSED STERILY TO THE FIELD IN ITS SILVER PACKAGES X3 (CONTENTS NOT VISIBLE) AND THE SCRUB TECH CONTINUED THEIR SET UP WHILE THE PATIENT WAS POSITIONED. SEVERAL MINUTES LATER WHEN THE SCRUB OPENED THE SILVER ORTHOBLEND PACKAGES IT WAS DISCOVERED THAT 1 OF THE 3 PACKAGES CONTAINED ALLOGRAFT THAT WAS DISCOLORED (BROWNISH) AS COMPARED TO THE OTHER 2 WHICH WERE NORMAL (BEIGE) IN COLOR. THE SURGICAL TEAM DECIDED TO DISCARD THE BROWNISH COLORED BONE GRAFT ( ORTHOBLEND) AND OPEN A NEW BOX OF 10 CC ORTHOBLEND. ALL BONE GRAFT LABELS ARE REQUIRED TO BE PLACED ON THE IMPLANT SHEET. AT THIS TIME IT WAS IMPOSSIBLE TO STATE WHICH BOX HAD THE DISCOLORED BONE GRAFT BECAUSE ALL 3 WERE OPENED AT THE SAME TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24257577 ↗
• InjurySep 5, 2025Off-Label Use; Off-Label Use

  INFORMATION WAS RECEIVED VIA A MANUFACTURER REPRESENTATIVE FROM PATIENT WHO WAS IMPLANTED WITH GRAFTON. IT WAS REPORTED THAT PATIENT WAS IMPLANTED WITH REPORTED GRAFTON DURING CERVICAL SPINE SURGERY ON (B)(6) 2020. DURING THIS SURGERY, THE GRAFTON BONE GRAFT PRODUCT WAS IMPLANTED IN PATIENT'S CERVICAL SPINE. PATIENT ALLEGED THAT USING GRAFTON IN THE CERVICAL SPINE WAS A DANGEROUS "OFF-LABEL" USE. FOLLOWING THE SURGERY AND IMPLANTATION OF GRAFTON, PATIENT SUFFERED SEVERE AND DEBILITATING INJURIES, INCLUDING BUT NOT LIMITED TO, UNCONTROLLED ECTOPIC BONE GROWTH, NERVE DAMAGE, NEED FOR ADDITIONAL SURGERIES, DAILY DEBILITATING NERVE PAIN, DECREASE IN MOBILITY AND MOVEMENTS OF THE NECK.

  Patient problems: Ambulation or Postural Difficulties; Extraskeletal ossification; Nerve Damage; Pain

  MAUDE report 22977055 ↗
• MalfunctionJul 7, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A GRAFTON. IT WAS REPORTED THAT THE PRODUCT BOX WAS OPENED AND THE INNER POUCH WAS NOT SEALED ON ONE SIDE. THE PRODUCT WAS NEVER COMPLETELY OPENED AS STERILITY WAS QUESTIONED AND NOT IMPLANTED IN THE PATIENT. THERE WAS NO PATIENT INVOLVEMENT.THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22410396 ↗
• MalfunctionJul 7, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  INFORMATION RECEIVED FROM USER FACILITY VIA A MANUFACTURING REPRESENTATIVE REGARDING A PART USED FOR SPINAL THERAPY. IT WAS REPORTED THAT SEAL WAS BROKEN PRIOR TO OPENING PRODUCT. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22410147 ↗
• InjuryAug 5, 2022Biocompatibility; Biocompatibility

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT POSTERIOR CERVICAL DECOMPRESSION/FUSION C4-7 DUE TO CERVICAL TUMOR (SCHWANOMA) IT WAS REPORTED THAT SURGEON HAD TO TAKE PATIENT BACK TO SURGERY DUE TO A CORD COMPRESSION FROM A FLUID COLLECTION. THE FLUID COLLECTION WASN'T BLOOD OR PUS. IT HAD THE APPEARANCE OF INFLAMMATORY FLUID AND HAD GRAFTON DBM MIXED IN WITH IT. IT IS SUSPECTED THAT THE PATIENT MIGHT HAVE HAD AN ALLERGIC REACTION TO ONE OF THE PROCESSING SOLUTIONS IN DBM (SURFACTANT OR ANTIBIOTICS). IT WAS ONLY MIXED WITH PATIENT OWN BONE. SINCE IT WASN'T A HEMATOMA, INFECTION, OR CSF LEAK, AND SINCE GRAFTON WAS FOUND MIXED IN THE COLLECTION, SURGEON BELIEVES IT WAS LIKELY A RARE ALLERGIC REACTION. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Hypersensitivity/Allergic reaction; Spinal Cord Injury; Swelling/ Edema

  MAUDE report 15173272 ↗
• InjuryAug 1, 2022Patient-Device Incompatibility

  THE PATIENT UNDERWENT POSTERIOR CERVICAL DECOMPRESSION AND FUSION FOR RESECTION OF A TUMOR. MEDTRONIC GRAFTON PLUS DBM (A STANDARD BONE GRAFT USED IN SPINE SURGERY) WAS USED AS ALLOGRAFT TO SUPPLEMENT THE LOCAL AUTOGRAFT. IT WAS APPLIED TO THE FACET JOINTS IN STANDARD FASHION. THE SPINAL CORD WAS COMPLETELY FREE OF COMPRESSION AT WOUND CLOSURE. A SURGICAL DRAIN WAS PLACED AND REMOVED POSTOP DAY 2 AFTER OUTPUT WAS SATISFACTORILY LOW. THE PATIENT WAS NEUROLOGICALLY STABLE UNTIL POSTOP DAY 5, WHEN SHE WHEN ACUTELY DECOMPENSATED FROM FULL 5/5 STRENGTH IN ALL EXTREMITIES TO 0/5 STRENGTH IN THE DISTAL UPPER EXTREMITIES AND ENTIRE LOWER EXTREMITIES. MRI DEMONSTRATED A LARGE FLUID COLLECTION IN THE SURGICAL BED CAUSING CORD COMPRESSION, AND THE PATIENT WAS EMERGENTLY RETURNED TO THE OPERATING ROOM. THE FLUID COLLECTION HAD A THIN, OFF-WHITE APPEARANCE WITH PIECES OF THE MEDTRONIC GRAFTON PLUS DBM MIXED IN WITH IT. THERE WAS NO HEMATOMA, PUS, OR CSF (MORE TYPICAL CAUSES OF POSTOPERATIVE COLLECTIONS). WE SUSPECT THAT THE PATIENT HAD AN ALLERGIC REACTION TO ONE OF THE PROCESSING AGENTS IN BONE GRAFT (E.G. SURFACTANT OR ANTIBIOTICS), A FLUID COLLECTION RESULTED FROM THE INFLAMMATORY RESPONSE.

  Patient problems: Hypersensitivity/Allergic reaction; Muscle Weakness/Atrophy; Nervous System Injury

  MAUDE report 15147850 ↗
• InjuryAug 23, 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 MANUFACTURING REPRESENTATIVE REGARDING A PATIENT WITH SPINAL STENOSIS F OR POSTEROLATERAL 2 LEVEL LUMBAR TLIF SPINAL FUSION THERAPY. IT WAS REPORTED THAT PATIENT HAD A BAD INFLAMMATORY RESPONSE AT THE SITE OF THE GRAFT. PATIENT HAD BACK PAIN, DOCTOR ADMITTED PATIENT TO HOSPITAL AND REMOVED ALL THE GRAFT. THE REVISION SURGERY WAS CONDUCTED ON (B)(6) 2021. THERE WAS NO INFECTION SUSPECTED, PRESENT, OR TREATED. THE PATIENT DIDN'T ACHIEVE SOLID FUSION. THERE WAS NO FURTHER INFORMATION REPORTED.

  Patient problems: Inflammation; Pain

  MAUDE report 12352252 ↗
• InjuryAug 23, 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 MANUFACTURING REPRESENTATIVE REGARDING A PATIENT WITH SPINAL STENOSIS F OR POSTEROLATERAL 2 LEVEL LUMBAR TLIF SPINAL FUSION THERAPY. IT WAS REPORTED THAT PATIENT HAD A BAD INFLAMMATORY RESPONSE AT THE SITE OF THE GRAFT. PATIENT HAD BACK PAIN, DOCTOR ADMITTED PATIENT TO HOSPITAL AND REMOVED ALL THE GRAFT. THE REVISION SURGERY WAS CONDUCTED ON (B)(6) 2021. THERE WAS NO INFECTION SUSPECTED, PRESENT, OR TREATED. THE PATIENT DIDN'T ACHIEVE SOLID FUSION. THERE WAS NO FURTHER INFORMATION REPORTED.

  Patient problems: Inflammation; Pain

  MAUDE report 12352249 ↗
• InjuryJan 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT POSTERIOR CERVICAL FIXATION AT C2-T1 DUE TO CERVICAL SPONDYLOSIS AND THE UNILATERAL OPEN-DOOR LAMINOPLASTY WERE PERFORMED. IN THE SURGERY, 5CC OF TISSUE HAS BEEN IMPLANTED IN THE PATIENT. POST-OP, THE PATIENT HAD INFECTION ON SAME LEVEL. PATIENT UNDERWENT REVISION SURGERY AS A RESULT OF THIS EVENT AND THE TISSUE WAS REMOVED FROM THE INFECTED SITE.

  Patient problems: Unspecified Infection

  MAUDE report 9537273 ↗
• InjuryFeb 27, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) AT L1-L4 DUE TO BACK AND RADICULAR PAIN. PO ST-OP, ALTHOUGH THE PATIENT HAS DONE WELL FROM A BACK PAIN AND RADICULAR PAIN STANDPOINT, SHE HAS HAD HIVES (AN ALLERGIC REACTION) INTERMITTENTLY SINCE HER IMPLANTATION. PATIENT DOES HAVE A LATEX ALLERGY, BUT WAS NOT KNOWINGLY EXPOSED TO LATEX DURING HER SURGERY.

  Patient problems: Reaction

  MAUDE report 7298641 ↗
• InjuryJan 2, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN (B)(6) 2015, PATIENT UNDERWENT A SURGERY WHERE TITANIUM PLATE AND SCREWS WERE IMPLANTED AT LEVELS C4-5 AND C5-6. REPORTEDLY, POST-OP, PATIENT HAD SWELLING ON HIS NECK, RHEUMATOID ARTHRITIS AND AUTO-IMMUNE DISEASE. REPORTEDLY, ¿PATIENT CANNOT WORK ANYMORE AND HIS SKIN NEAR NECK HAS TURNED RED.¿ PATIENT ALSO HAS A TUMOR. ALLERGY TEST REVEALED THAT THE PATIENT IS ALLERGIC TO NICKEL AND CHROMIUM. THE DOCTORS DO NOT KNOW WHAT THE SYMPTOMS ARE RELATED TO AND NOW ARE LOOKING AT THE DEVICES TO SEE IF HE MIGHT BE ALLERGIC TO THE DEVICES.

  Patient problems: Autoimmune Disorder; Rheumatoid Arthritis; Skin Discoloration; Swelling

  MAUDE report 6217070 ↗
• InjuryJan 2, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN (B)(6) 2015, PATIENT UNDERWENT A SURGERY WHERE TITANIUM PLATE AND SCREWS WERE IMPLANTED AT LEVELS C4-5 AND C5-6. REPORTEDLY, POST-OP, PATIENT HAD SWELLING ON HIS NECK, RHEUMATOID ARTHRITIS AND AUTO-IMMUNE DISEASE. REPORTEDLY, ¿PATIENT CANNOT WORK ANYMORE AND HIS SKIN NEAR NECK HAS TURNED RED.¿ PATIENT ALSO HAS A TUMOR. ALLERGY TEST REVEALED THAT THE PATIENT IS ALLERGIC TO NICKEL AND CHROMIUM. THE DOCTORS DO NOT KNOW WHAT THE SYMPTOMS ARE RELATED TO AND NOW ARE LOOKING AT THE DEVICES TO SEE IF HE MIGHT BE ALLERGIC TO THE DEVICES.

  Patient problems: Autoimmune Disorder; Rheumatoid Arthritis; Skin Discoloration; Swelling

  MAUDE report 6217069 ↗

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