PRESTIGE LP Cervical Disc SystemRecalls & reported problems across all models

We found 11 models of PRESTIGE LP Cervical Disc System by Medtronic Sofamor Danek, Inc. in the FDA's device registry (GUDID). Together they are named in 47 adverse event reports in the FDA's MAUDE database, received between Nov 15, 2016 and Aug 31, 2026 — classified as 38 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (7 reports).

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

Most reported PRESTIGE LP Cervical Disc System problems

PRESTIGE LP Cervical Disc System models

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

• PRESTIGE® LP Cervical Disc System 6972660

  PROSTHESIS, INTERVERTEBRAL DISC
  15 reports
• PRESTIGE® LP Cervical Disc System 6972860

  PROSTHESIS, INTERVERTEBRAL DISC
  9 reports
• PRESTIGE® LP Cervical Disc System 6972460

  PROSTHESIS, INTERVERTEBRAL DISC
  6 reports
• PRESTIGE® LP Cervical Disc System 6973060

  PROSTHESIS, INTERVERTEBRAL DISC
  4 reports
• PRESTIGE® LP Cervical Disc System 6972870

  PROSTHESIS, INTERVERTEBRAL DISC
  3 reports
• PRESTIGE® LP Cervical Disc System 6973000

  PROSTHESIS, INTERVERTEBRAL DISC
  3 reports
• PRESTIGE® LP Cervical Disc System 6972670

  PROSTHESIS, INTERVERTEBRAL DISC
  2 reports
• PRESTIGE® LP Cervical Disc System 6972470

  PROSTHESIS, INTERVERTEBRAL DISC
  2 reports
• PRESTIGE® LP Cervical Disc System 6973246

  PROSTHESIS, INTERVERTEBRAL DISC
  1 report
• PRESTIGE® LP Cervical Disc System 6972260

  PROSTHESIS, INTERVERTEBRAL DISC
  1 report
• PRESTIGE® LP Cervical Disc System 6973070

  PROSTHESIS, INTERVERTEBRAL DISC
  1 report

Recent PRESTIGE LP Cervical Disc System adverse event reports

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

• MalfunctionAug 31, 2026Mechanical Problem; Material Twisted/Bent

  Information was received from multiple sources (Manufacturer Representative, Healthcare Provider) regarding a device used for cervic al arthroplasty Spinal therapy at C5/6. It was reported that the inserters had difficulty seating all four inserter dimples into the interbody. Three of four dimples could be seated, but a snug fit could not be achieved before tightening the locking knob to secure the implant. There was difficulty attaching and locking the implant, including tightening the locking knob. The inserter prongs or dimples were suspected to be bent or unaligned; however, no visible damage was confirmed. There was no patient involved.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50516719 ↗
• MalfunctionAug 3, 2026Mechanical Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50113616 ↗
• MalfunctionJun 30, 2026Mechanical Problem

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT, INSERTER HANDLE DOSE NOT STOP SPINNING ONCE THE IMPLANT IS LOCKED IN. INSTRUMENT WAS USED FOR CERVICAL DISC REPLACEMENT. THERE WAS NO PATIENT INVOLVEMENT REPORTED. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25662572 ↗
• MalfunctionFeb 9, 2026Degraded; Mechanical Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) PROCEDURE AT LEVELS 5-7 FOR A PRE-OPERATIVE DIAGNOSIS OF HERNIATED NUCLEUS PULPOSUS. IT WAS REPORTED THAT THREE INSERTERS HAVE BEEN BROKEN AND NO LONGER ATTACHED TO THE IMPLANTS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THERE WAS AN INSTRUMENT INCOMPATIBILITY WHICH MIGHT BE DUE TO WEAR ISSUE AND NOT BREAKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24288729 ↗
• MalfunctionFeb 8, 2026Degraded; Mechanical Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) PROCEDURE AT LEVELS 5-7 FOR A PRE-OPERATIVE DIAGNOSIS OF HERNIATED NUCLEUS PULPOSUS. IT WAS REPORTED THAT THREE INSERTERS HAVE BEEN BROKEN AND NO LONGER ATTACHED TO THE IMPLANTS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THERE WAS AN INSTRUMENT INCOMPATIBILITY WHICH MIGHT BE DUE TO WEAR ISSUE AND NOT BREAKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24288233 ↗
• InjuryDec 29, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SMITH ROBINSON TECHNIQUE TO IMPLANT PRESTIGE DISC AT THE LEVEL C6/7. IT WAS REPORTED THAT, SURGEON ORDERED AN X-RAY WHICH SHOWED THE DEVICE HAD ROTATED. THE PATIENT DEVELOPED PAIN AT THE LEVEL OF OPERATION MULTIPLE MONTHS AFTER POST OP. THE DEVICE WAS EXPLANTED AND PERFORMED ANTERIOR CERVICAL DISCECTOMY AND FUSION. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Pain

  MAUDE report 23905218 ↗
• MalfunctionAug 29, 2025Inadequacy of Device Shape and/or Size; Migration; Inadequacy of Device Shape and/or Size; Migration

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER, CLINICAL STUDY) REGARDING AN EVENT WHICH OCCURRED POST A CLINICAL STUDY (STUDY ID: (B)(4) SPINAL FUSION PROCEDURE IN A PATIENT (PATIENT ID: (B)(6). PATIENT MEDICAL HISTORY: ARTHRITIS, HYPERLIPIDEMIA, HYPERTENSION IT WAS REPORTED THAT, POST CRANIAL SPINE SURGERY C6-C7, AS PER INVESTIGATOR ASSESSMENT IT WAS CONFIRMED THAT IMPLANTED DEVICES DOES NOT APPEAR STABLE AND SECURE. THE PATIENT EXPERIENCED EVIDENCE OF IMPLANT SUBSIDENCE POSTOPERATIVELY. THE EVENT IS SUSPECTED TO BE DEVICE-RELATED DUE TO ANATOMICAL AND BIOMECHANICAL MISMATCH. THE PATIENT IS APPROXIMATELY 7 FEET TALL, AND THE LARGEST AVAILABLE IMPLANT WAS USED; HOWEVER, IT DID NOT PROVIDE FULL ENDPLATE COVERAGE AND RESULTED IN AN ANTERIOR SHIFT OF THE CENTRE OF ROTATION. THIS SUBOPTIMAL IMPLANT POSITIONING AND SIZE MAY HAVE CONTRIBUTED TO INCREASED AXIAL LOAD CONCENTRATION AND INADEQUATE LOAD DISTRIBUTION ACROSS THE ENDPLATE, LEADING TO IMPLANT SETTLING OR SINKING (SUBSIDENCE) INTO THE VERTEBRAL BODY. THE SUBSIDENCE WAS NOT IMMEDIATELY EVIDENT INTRAOPERATIVELY BUT WAS LATER CONFIRMED ON FOLLOW-UP IMAGING OBTAINED AT THE 1-MONTH FOL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22920420 ↗
• MalfunctionAug 25, 2025Crack; Crack

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR CERVICAL DISC ARTHROPLASTY. IT WAS REPORTED THAT THE PART OF THE INSTRUMENT THAT HOLDS THE IMPLANT WAS CRACKED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22881848 ↗
• InjuryApr 4, 2024Migration; Migration

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PRE-OPERATIVE DI AGNOSIS FOR C5-6 ARTHROPLASTY. PROCEDURE OR TECHNIQUE USED WAS ARTHROPLASTY. LEVELS IMPLANTED C5-6. IT WAS REPORTED THAT THE DEVICE SEEMED TO HAVE KICKED OUT ANTERIORLY AFTER SURGERY. THE SURGEON PLANS TO REMOVE THIS DEVICE ON FRIDAY (B)(6) 2024 AND COMPLETE A C5-6 ACF IN ITS PLACE. IMPLANT BACKED OUT ANTERIORLY POST-OP OR IF THE IMPLANT WAS NEVER FULLY SEATED IN THE DISC SPACE. IT APPEARED TO EVERYONE THE IMPLANT WAS IN A DESIRABLE POSITION INTRA-OP BUT THEN IT APPEARED TO HAVE KICKED OUT ON THE NEXT DAY POST-OP IMAGES. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. REVISION SURGERY WAS PERFORMED. THE SURGEON EXPLANTED THE ARTHROPLASTY DEVICE AND DID A C5-6 ACF. THE DEVICE WAS REMOVED ON (B)(6) 2024. THE SURGEON WAS SATISFIED WITH THE SURGERY AND THE PATIENT IS DOING WELL POST OP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19040866 ↗
• InjuryNov 14, 2023Migration; Migration

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING DEVICE USED FOR CERVICAL FUSION. LEVELS: C5/6 IT WAS REPORTED THAT CAGE SETTLING OCCURRED. THE CAGE SETTLED A COUPLE MILLIMETERS INTO THE END PLATE OF THE VERTEBRAL BODIES. DUE TO THIS, THE SURGEON PERFORMED A ACDF USING CAGE AND PLATE. ADDITIONAL SURGERY WAS PERFORMED TO EXPLANT THE CAGE USING DISTRACTION AND KOCHER CLAMP. PATIENT HAD INFECTION. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 18128725 ↗
• InjuryDec 30, 2022Material Fragmentation; Mechanical Problem; Material Fragmentation; Mechanical Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR UNKNOWN INDICATION. IT WAS REPORTED THAT TWO PRESTIGE LP DISC EXPLANTED. PRODUCTS WILL BE RETURNED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE THAT C6 COLLAPSED AND A CORPECTOMY HAD TO BE PERFORMED. DEBRIS WAS FOUND IN THE DISC SPACE. PROCEDURE INVOLVED WAS C5-7 CORPECTOMY. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16076171 ↗
• InjurySep 12, 2022Migration; Migration

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA THE MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING USE. IT WAS REPORTED THAT THERE WAS CAGE SUBSIDENCE AND MIGRATION. THE PRODUCT WAS EXPLANTED AND THERE WAS A REVISION FUSION SURGERY. NO OTHER PATIENT SYMPTOM / COMPLICATION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15401986 ↗
• InjurySep 12, 2022Migration; Migration

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA THE MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING USE. IT WAS REPORTED THAT THE C6 IMPLANT SETTLED WITH RECURRENT SYMPTOMS. THE PRODUCT WAS EXPLANTED USING DISTRACTION AND OSTEOTOME AND REPLACED WITH A MEDTRONIC PRODUCT. NO OTHER PATIENT SYMPTOM / COMPLICATION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15401980 ↗
• InjuryApr 15, 2021Biocompatibility; Biocompatibility

  INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROFESSIONAL (HCP) VIA THE MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED POST-OP A SPINAL FUSION PROCEDURE PERFORMED LEVELS 5/6 IN A PATIENT. IT WAS REPORTED THAT THE PATIENT HAD OSTEOLYSIS, KYPHOSIS AND POSSIBLE REACTION OR REJECTION TO TITANIUM. PRODUCT WILL BE RETURNED.

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

  MAUDE report 11669857 ↗
• InjuryDec 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THERE WAS NO PRODUCT MALFUNCTION.

  Patient problems: Unspecified Infection

  MAUDE report 11034487 ↗

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