PRESTIGE® LP Cervical Disc System 6972660Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00613994493668), received between Jan 3, 2017 and Apr 4, 2024 — classified as 15 injuries.

The most frequently reported specific device problem is “Malposition of Device” (2 reports).

1 other recall cover devices cleared under the same FDA submission (P090029); 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• InjuryAug 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT SPINAL THERAPY FOR ARTIFICIAL DISC REPLACEMENT (ADR). IT WAS REPORTED THAT THE ADDITIONAL SURGERY WAS PERFORMED SINCE THE PATIENT HAD LOSS OF MOTOR SENSATION. THERE WAS PATIENT INVOLVED IN THE EVENT AND HAD INJURY REPORTED AS LOSS OF MOVEMENT IN LIMBS.

  Patient problems: Neurological Deficit/Dysfunction

  MAUDE report 10429747 ↗
• InjuryMar 6, 2020Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH C6-C7 DISC HERNIATION; AND UNDERWENT TOTAL DISC ARTHROPLASTY AT C6-C7. TWO WEEKS POST-OP, IT WAS FOUND THAT THE IMPLANT HAD MIGRATED FROM ITS PLACE. HENCE, A REVISION SURGERY WAS PERFORMED, AND THE MIGRATED IMPLANT WAS COMPLETELY EXPLANTED. ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) WAS ALSO PERFORMED AS A RESULT OF THIS EVENT. THE PATIENT UNDERWENT THE DISCECTOMY AT C6-C7 FOR AN EXTREMELY LARGE DISK RUPTURE AT C6-7 DIRECT TO THE LEFT SIDE.

  Patient problems: Rupture

  MAUDE report 9802260 ↗
• InjurySep 18, 2019Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE PATIENT UNDERWENT ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) AT C6-7 DUE TO CERVICAL RADICULOPATHY. POST-OP, THE IMPLANT WAS TOO BIG, SO SURGEON REPLACED IT WITH A PLATE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9080760 ↗
• InjuryJun 26, 2019Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT ON (B)(6) 2017, THE PATIENT UNDERWENT CERVICAL ARTHROPLASTY AT C5-C6 DUE TO RADICULOPATHY. ON AN UNKNOWN DATE, AROUND 6 WEEKS POST-OPERATIVELY, SWALLOWING DIFFICULTIES WERE EXPERIENCED BY THE PATIENT. IT WAS FOUND THAT THE IMPLANT WAS PLACED TOO PROUD. HENCE, ON (B)(6) 2019, A REVISION SURGERY WAS PERFORMED AND THE DISC REPLACEMENT SURGERY WAS CONVERTED TO SINGLE LEVEL ANTERIOR CERVICAL DISCECTOMY AND FUSION. THE ARTIFICIAL DISC WAS EXPLANTED IN THIS REVISION SURGERY AND WAS REPLACED BY CAGE AND SCREWS.

  Patient problems: Dysphagia/ Odynophagia

  MAUDE report 8735697 ↗
• InjuryJan 9, 2019Adverse 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 RADICULOPATHY, HERNIATED DISC, CERVICAL DEGENERATIVE DISC DISEASE AND UNDERWENT EXTRAPHARYNGEAL ANTEROLATERAL APPROACH SURGERY AT C5-C6, C6-C7 LEVELS. POST-OPERATIVELY, DURING A ROUTINE VISIT TO THE HOSPITAL, THE PATIENT COMPLAINED OF A RIGHT FOREARM NUMBNESS APPROXIMATELY ONE TIME IN A TWO WEEK PERIOD THAT WAS NOT PRESENT PRE-SURGERY. NO DEVICE MALFUNCTION WAS REPORTED. THE PATIENT OUTCOME WAS REPORTED AS BEING PENDING. THE PATIENT WAS TREATED WITH PHYSICAL THERAPY.

  Patient problems: Numbness

  MAUDE report 8230214 ↗
• InjuryJan 9, 2019Adverse 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 RADICULOPATHY, HERNIATED DISC, CERVICAL DEGENERATIVE DISC DISEASE AND UNDERWENT EXTRAPHARYNGEAL ANTEROLATERAL APPROACH SURGERY AT C5-C6, C6-C7 LEVELS. POST-OPERATIVELY, DURING A ROUTINE VISIT TO THE HOSPITAL, THE PATIENT COMPLAINED OF A RIGHT FOREARM NUMBNESS APPROXIMATELY ONE TIME IN A TWO WEEK PERIOD THAT WAS NOT PRESENT PRE-SURGERY. NO DEVICE MALFUNCTION WAS REPORTED. THE PATIENT OUTCOME WAS REPORTED AS BEING PENDING. THE PATIENT WAS TREATED WITH PHYSICAL THERAPY.

  Patient problems: Numbness

  MAUDE report 8230211 ↗
• InjuryNov 29, 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 RADICULOPATHY, HERNIATED DISC, CERVICAL DEGENERATIVE DISC DISEASE AND UNDERWENT EXTRAPHARYNGEAL ANTEROLATERAL APPROACH SURGERY AT C5-C6, C6-C7 LEVELS. POST-OPERATIVELY, DURING A ROUTINE VISIT TO THE HOSPITAL, THE PATIENT COMPLAINED OF A MILD HOARSE VOICE AND DIFFICULTY SWALLOWING. THE SEVERITY OF THE PAIN WAS ASSESSED AS BEING MILD. IT WAS ALLEGED THAT THE PAIN WAS RELATED TO THE SURGICAL PROCEDURE AND LIKELY RELATED TO INTUBATION. THE PATIENT OUTCOME WAS REPORTED AS BEING PENDING.

  Patient problems: Dysphagia/ Odynophagia

  MAUDE report 8114336 ↗
• InjuryNov 29, 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 RADICULOPATHY, HERNIATED DISC, CERVICAL DEGENERATIVE DISC DISEASE AND UNDERWENT EXTRAPHARYNGEAL ANTEROLATERAL APPROACH SURGERY AT C5-C6, C6-C7 LEVELS. POST-OPERATIVELY, DURING A ROUTINE VISIT TO THE HOSPITAL, THE PATIENT COMPLAINED OF A MILD HOARSE VOICE AND DIFFICULTY SWALLOWING. THE SEVERITY OF THE PAIN WAS ASSESSED AS BEING MILD. IT WAS ALLEGED THAT THE PAIN WAS RELATED TO THE SURGICAL PROCEDURE AND LIKELY RELATED TO INTUBATION. THE PATIENT OUTCOME WAS REPORTED AS BEING PENDING.

  Patient problems: Dysphagia/ Odynophagia

  MAUDE report 8114330 ↗
• InjuryDec 8, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT ANTERIOR DISC REPLACEMENT AT C5-6 DUE TO CERVICAL DISC HERNIATION. POST-OP, POSTERIOR OSTEOPHYTIC CHANGES WERE OBSERVED. HENCE, REVISION ACDF (ANTERIOR CERVICAL DISCECTOMY AND FUSION) AND REMOVAL OF IMPLANT WAS PERFORMED NO PRODUCT MALFUNCTION WAS REPORTED.

  Patient problems: Extraskeletal ossification

  MAUDE report 7099314 ↗
• InjuryJun 12, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PROCEDURE: CERVICAL ARTHROPLASTY THAT ENDED UP BEING AN ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) IT WAS REPORTED THAT AFTER OPENING THE BOX DURING SURGERY, SURGEON REALIZED THAT THE HEIGHT OF THE IMPLANT WAS TOO MUCH. THE PROCEDURE WAS CHANGED FROM ARTHROPLASTY TO ACDF. NO MALFUNCTION OF THE IMPLANT WAS REPORTED. THE SURGERY WAS COMPLETED WITH ANOTHER IMPLANT.

  Patient problems: No Code Available

  MAUDE report 6632931 ↗
• InjuryFeb 7, 2017Material Erosion; Material Erosion

  IT WAS REPORTED THAT ON (B)(6) 2014, THE PATIENT UNDERWENT SURGERY AT LEVELS C6-C7; C4-C5 WITH IMPLANTATION OF ARTIFICIAL CERVICAL DISC AT LEVEL C6-C7 DUE TO PRE-OP DIAGNOSIS: NECK PAIN, DISC HERNIATION. ON (B)(6) 2014, THE PATIENT UNDERWENT ANTERIOR CERVICAL DISC FUSION(ACDF) SURGERY AT LEVELS C4-C5,C5-C6,C6-C7 WITH IMPLANTATION OF ANOTHER ARTIFICIAL CERVICAL DISC. ON (B)(6) 2017, THE PATIENT UNDERWENT A REVISION SURGERY IN WHICH BOTH THE DISCS IMPLANTED WERE REMOVED. THE SURGEON STATED THAT THE PATIENT HAD A BRIEF PERIOD OF NECK PAIN RELIEF BUT THAT THE NECK PAIN HAS CONTINUED AND THE PATIENT WAS ALSO EXPERIENCING OCCIPITAL HEADACHES. DISCS WERE BEING REMOVED DUE TO PERSISTENT NECK PAIN. REMOVAL OF BOTH DISCS WERE UNCOMPLICATED BUT SURGEON NOTED SOME HETEROTOPIC OSSIFICATION (GRADE 1) POSTEROLATERAL TO ARTIFICIAL DISC REPLACEMENT DEVICE. "HO" WAS REMOVED WITH DRILL. THE ARTIFICIAL DISC REPLACEMENT DEVICE PLUS PERI-PROSTHETIC TISSUE WAS SENT FOR ANALYSIS PER FDA REQUIREMENTS. REVISION TREATMENT INCLUDED THREE LEVEL USING PEEK PLUS ANTERIOR PLATE. TISSUE INGROWTH WAS OBSERVED BETWEEN SUPERIOR AND INFERIOR DEVICE COMPONENTS. METAL DEBRIS WAS VISIBLE IN TISSUE LATERAL TO LP DEVICE. T

  Patient problems: Headache; Inadequate Pain Relief; Neck Pain

  MAUDE report 6309841 ↗
• InjuryJan 30, 2017Metal Shedding Debris; Metal Shedding Debris

  IT WAS REPORTED THAT ON (B)(6) 2015, THE PATIENT UNDERWENT A SURGERY, IN WHICH THE ARTIFICIAL DISC WAS IMPLANTED AT LEVELS C6-C7. ON AN UNKNOWN DATE, POST-OP, ALLEGEDLY, THE PATIENT EXPERIENCED CHRONIC NECK PAIN. THE SURGEON SUSPECTED LACK OF BONY IN GROWTH AS REASON FOR PATIENT PAIN. ON (B)(6) 2017, THE PATIENT UNDERWENT REVISION SURGERY, IN WHICH THE ARTIFICIAL DISC WAS EXPLANTED FROM LEVEL C6/7 WITH OSTEOTOME AND KOCHER. AT EXPLANT, THE SURGEON REQUIRED "NO EFFORT" TO DISLODGE THE IMPLANT FROM THE SITE. THE SURGEON REPORTED THAT THE IMPLANT WAS WELL ALIGNED WITH GOOD PLACEMENT. EXPLANT OF ADJACENT ANTERIOR CERVICAL DISKECTOMY AND FUSION (ACDF) PLATE SCREWS WAS PERFORMED FIRST WITH ARTIFICIAL DISC REMOVAL TO FOLLOW. THE SURGEON ALSO REMOVED SOME OSTEOPHYTES FROM AROUND THE PLATE PRIOR TO EXPLORING ARTIFICIAL DISC. THE SURGEON OBSERVED METALLOSIS IN THE DISC SPACE AFTER REMOVAL. THE ARTIFICIAL DISC WAS REPLACED WITH A PRODUCT, MANUFACTURED BY ANOTHER MANUFACTURER. THE PATIENT ALSO UNDERWENT ANTERIOR CERVICAL DISKECTOMY AND FUSION (ACDF) SURGERY WITH ILIAC CREST BONE GRAFT AT C6/7.

  Patient problems: Neck Pain; No Code Available

  MAUDE report 6286524 ↗
• InjuryJan 3, 2017Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT ON (B)(6) 2015 (MONTH AND YEAR VALID), PATIENT UNDERWENT SURGERY. REPORTEDLY, POST-OP, PATIENT SUFFERED WITH NECK PAIN, PAIN IN THE SHOULDER THAT EXTENDED ACROSS CHEST. PATIENT ALSO COMPLAINED OF NUMBNESS AND TINGLING IN FINGERS. FOR WHICH, ON (B)(6) 2016, PATIENT UNDERWENT FUSION REVISION SURGERY AT LEVELS C5/C6. THE SURGEON FELT THAT THERE WAS FORWARD TRANSLATION OF SUPERIOR DEVICE COMPONENT BASED ON FLEXION/EXTENSION X-RAYS. UPON PERFORMING ANTERIOR CERVICAL APPROACH FROM THE RIGHT SIDE, THE SURGEON NOTED THAT THE DEVICE WAS IMPLANTED OFF MIDLINE TO THE LEFT, ANGLED TOWARD HIM. NO PATIENT COMPLICATIONS WERE REPORTED IN THE REVISION SURGERY.

  Patient problems: Chest Pain; Neck Pain; Numbness; Tingling

  MAUDE report 6217752 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P090029. One submission often covers many models, so check the product and lot details in each record.

• Z-1641-2018 · Mar 13, 2018 · Terminated
  Medtronic Prestige LP(TM) Cervical Disc System with Streamlined Instruments, DRILL GUIDES: a) REF 6975205, 5mm b) REF 6975206, 6mm c) REF 6975207, 7mm Product Usage: The PRESTIGE