Centerpiece Plate Fixation SystemRecalls & reported problems across all models
Medtronic Sofamor Danek, Inc. · 5 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 29
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls
- 0
We found 5 models of Centerpiece Plate Fixation System by Medtronic Sofamor Danek, Inc. in the FDA's device registry (GUDID). Together they are named in 29 adverse event reports in the FDA's MAUDE database, received between Jan 18, 2017 and Mar 2, 2026 — classified as 1 injury, 28 malfunctions.
The most frequently reported specific device problem is “Break” (27 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
Reports received per month, all models
Most reported Centerpiece Plate Fixation System problems
Device problems
- Break27
- Adverse Event Without Identified Device or Use Problem1
- Difficult to Insert1
- Improper or Incorrect Procedure or Method1
- Product Quality Problem1
Patient problems
- Device Embedded In Tissue or Plaque22
- No Clinical Signs, Symptoms or Conditions8
- Muscle Weakness/Atrophy1
- Neck Pain1
- No Code Available1
Centerpiece Plate Fixation System models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Centerpiece Plate Fixation System 8532065ORTHOSIS, SPINE, PLATE, LAMINOPLASTY, METAL13 reports
- Centerpiece Plate Fixation System 8532067ORTHOSIS, SPINE, PLATE, LAMINOPLASTY, METAL11 reports
- Centerpiece Plate Fixation System G8532067ORTHOSIS, SPINE, PLATE, LAMINOPLASTY, METAL3 reports
- CENTERPIECE™ Plate Fixation System 853-467Screw, fixation, bone1 report
- CENTERPIECE™ Plate Fixation System 853010WMORTHOSIS, SPINE, PLATE, LAMINOPLASTY, METAL1 report
Recent Centerpiece Plate Fixation System adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMar 2, 2026Break
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING A C3, C4, C5, C6 LAMINOPLASTY PROCEDURE FOR CERVICAL SPINAL COMPRESSION. IT WAS REPORTED THAT UPON HAND TIGHTENING THE SCREW, THE 2 SCREWS BROKE LEAVING THE HEAD PART OF THE SCREW OUT AND THE REMAINING PART OF THE SCREW INSIDE THE PATIENT. THERE WAS NO SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: Device Embedded In Tissue or Plaque; No Clinical Signs, Symptoms or Conditions
MAUDE report 24482455 ↗MalfunctionMar 2, 2026Break
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING A C3, C4, C5, C6 LAMINOPLASTY PROCEDURE FOR CERVICAL SPINAL COMPRESSION. IT WAS REPORTED THAT UPON HAND TIGHTENING THE SCREW, THE 2 SCREWS BROKE LEAVING THE HEAD PART OF THE SCREW OUT AND THE REMAINING PART OF THE SCREW INSIDE THE PATIENT. THERE WAS NO SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: Device Embedded In Tissue or Plaque; No Clinical Signs, Symptoms or Conditions
MAUDE report 24482448 ↗MalfunctionDec 29, 2025Break; Break
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR LAMINOPLASTY. IT WAS REPORTED THAT THE HEAD OF A BONE SCREW BROKE DURING INTRODUCTION, RESULTING IN THE SCREW BODY REMAINING IN THE PATIENT AS A RETAINED IMPLANT FRAGMENT. IT WAS CONFIRMED THAT THE PRODUCT WAS UTILIZED ACCORDING TO THE DIRECTIONS FOR USE. NO TREATMENT OR ADDITIONAL SURGERY WAS PERFORMED AS A RESULT OF THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS OR SYMPTOMS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED FROM MANUFACTURER REPRESENTATIVE THAT THERE IS NO REVISION SURGERY SCHEDULED OR PLANNED FOR THE REMOVAL OF BROKEN FRAGMENTS FROM PATIENT. THIS EVENT HAS BEEN OCCURRED DUE TO POTENTIAL MANUFACTURING ISSUE OF THE DEVICE.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 23905444 ↗MalfunctionApr 23, 2025Break; Break
INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING BONE SCREWS USED IN LAMINOPLASTY C3-7 THERAPY FOR CERVICAL STENOSIS. IT WAS REPORTED THAT THE THREADED PORTION OF THE SCREW BROKE OFF IN THE CORRESPONDING LEVELS AND ANATOMY - ONE AT C6 LAMINA AND TWO AT C7 LATERAL MASS. FRAGMENT OF THE IMPLANT WAS REMAINING IN THE PATIENT. NO ADDITIONAL SURGERY WAS PERFORMED. NO PATIENT SYMPTOMS WERE REPORTED. PATIENT'S MEDICAL HISTORY INCLUDES ALLERGIES TO IODINE, IV CONTRAST. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 21887617 ↗MalfunctionApr 22, 2025Break; Break
INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING BONE SCREWS USED IN LAMINOPLASTY C3-7 THERAPY FOR CERVICAL STENOSIS. IT WAS REPORTED THAT THE THREADED PORTION OF THE SCREW BROKE OFF IN THE CORRESPONDING LEVELS AND ANATOMY - ONE AT C6 LAMINA AND TWO AT C7 LATERAL MASS. FRAGMENT OF THE IMPLANT WAS REMAINING IN THE PATIENT. NO ADDITIONAL SURGERY WAS PERFORMED. NO PATIENT SYMPTOMS WERE REPORTED. PATIENT'S MEDICAL HISTORY INCLUDES ALLERGIES TO IODINE, IV CONTRAST. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 21883158 ↗MalfunctionApr 22, 2025Break; Break
INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH A BONE SCREW USED IN LAMINOPLASTY WITH CENTERPIECE 2.0. NORMAL TECHNIQUE FOR STENOSIS. IT WAS REPORTED THE THREE CENTERPIECE SCREWS BROKE AND ONE OF WHICH HCP WAS UNABLE TO RETRIEVE AND THEREFORE THE REMAINDER OF THE SCREW WAS LEFT IN THE PATIENT. LEVELS IMPLANTED WAS C4-C6. THERE WAS NO ADDITIONAL SURGERY NEEDED FROM THIS EVENT, AND THERE IS NO PLAN TO REMOVE THE BROKEN SCREW LEFT INSIDE THE PATIENT. THE PROCEDURE WAS DONE SUCCESSFULLY. BUT THERE WAS A SMALL DELAY IN THE PROCEDURE WHEN TRYING TO RETRIEVE ONE OF THE SCREWS. THIS DELAY MIGHT HAVE LASTED FOR APPROXIMATELY 20 SECONDS. NO ADVERSE EVENT OCCURRED TO PATIENT. THERE WERE NO FURTHER COMPLICATIONS THAT WERE REPORTED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 21880919 ↗MalfunctionApr 22, 2025Break; Break
INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH A BONE SCREW USED IN LAMINOPLASTY WITH CENTERPIECE 2.0. NORMAL TECHNIQUE FOR STENOSIS. IT WAS REPORTED THE THREE CENTERPIECE SCREWS BROKE AND ONE OF WHICH HCP WAS UNABLE TO RETRIEVE AND THEREFORE THE REMAINDER OF THE SCREW WAS LEFT IN THE PATIENT. LEVELS IMPLANTED WAS C4-C6. THERE WAS NO ADDITIONAL SURGERY NEEDED FROM THIS EVENT, AND THERE IS NO PLAN TO REMOVE THE BROKEN SCREW LEFT INSIDE THE PATIENT. THE PROCEDURE WAS DONE SUCCESSFULLY. BUT THERE WAS A SMALL DELAY IN THE PROCEDURE WHEN TRYING TO RETRIEVE ONE OF THE SCREWS. THIS DELAY MIGHT HAVE LASTED FOR APPROXIMATELY 20 SECONDS. NO ADVERSE EVENT OCCURRED TO PATIENT. THERE WERE NO FURTHER COMPLICATIONS THAT WERE REPORTED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 21880890 ↗MalfunctionApr 22, 2025Break; Break
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING C4-6 LAMINOPLASTY FOR C3-7 STENOSIS. IT WAS REPORTED THAT THE SCREW FRACTURED WHILE HALF WAY INSERTED.. A PORTION OF THE SCREW WAS EXPLANTED, THE OTHER PIECE STILL REMAINS IN PATIENT. THERE WAS NO PATIENT SYMPTOM REPORTED. NO HOSPITALIZATION/PROLONGATION OF EXISTING HOSPITALIZATION WAS NECESSARY AND NO ADDITIONAL/REVISION SURGERY PERFORMED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 21879565 ↗MalfunctionApr 22, 2025Break; Break
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING C4-6 LAMINOPLASTY FOR C3-7 STENOSIS. IT WAS REPORTED THAT THE SCREW FRACTURED WHILE HALF WAY INSERTED. A PORTION OF THE SCREW WAS EXPLANTED, THE OTHER PIECE STILL REMAINS IN PATIENT. THERE WAS NO PATIENT SYMPTOM REPORTED. NO HOSPITALIZATION/PROLONGATION OF EXISTING HOSPITALIZATION WAS NECESSARY AND NO ADDITIONAL/REVISION SURGERY PERFORMED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 21879528 ↗MalfunctionApr 22, 2025Break; Break
INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING SCREWS USED IN LAMINOPLASTY THERAPY. LEVELS IMPLANTED: 2. IT WAS REPORTED THAT THE SURGEON HAD FOLLOWED THE STEPS IN THE CENTERPIECE 2.0 SURGICAL TECHNIQUE BUT IT STILL RESULTED IN THE BREAKING OF 2 SCREWS DURING IMPLANTING. THE SCREWS HAVE BEEN EXPLANTED PARTIALLY AS THE SCREWS BROKE OFF AT NECK. THE SCREW THREADS ARE REMAINING IN THE PATIENT. PATIENT SYMPTOMS ARE UNKNOWN. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 21879361 ↗MalfunctionMar 26, 2025Break; Break
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING LAMINOPLASTY (L EVELS IMPLANTED C3-C7) DUE TO UNKNOWN INDICATION. IT WAS REPORTED THAT 2.0 X 7 MM CENTERPIECE 2.0 X2 SCREWS BROKE IN HALF RIGHT UNDER THE POST HEAD OF THE CENTERPIECE 2.0 SCREW DURING IMPLANTING. THE SURGEON DRILLED WITH THE 1.3 X 7 MM DRILL THEN PLACED THE SCREW IMMEDIATELY FOLLOWING HE MENTION THE BONE WAS A LITTLE HARD HOWEVER THEY SNAPPED OFF PRETTY EASY. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21696169 ↗MalfunctionFeb 10, 2025Break; Break
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING C4-6 LAMINOPLASTY FOR C3-7 STENOSIS. IT WAS REPORTED THAT THE SCREW FRACTURED WHILE HALFWAY INSERTED. A PORTION OF THE SCREW WAS EXPLANTED, THE OTHER PIECE STILL REMAINS IN PATIENT. THERE WAS NO PATIENT SYMPTOM REPORTED. NO HOSPITALIZATION/PROLONGATION OF EXISTING HOSPITALIZATION WAS NECESSARY AND NO ADDITIONAL/REVISION SURGERY PERFORMED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 21341425 ↗MalfunctionJan 25, 2025Break; Break
INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING A BONE SCREW USED IN LAMINOPLASTY THERAPY FOR NECK PAIN. LEVELS IMPLANTED: C3-C7 IT WAS REPORTED THAT PER THE HEALTHCARE PROFESSIONAL, WHEN TAKING THE SCREWDRIVER OFF THE SCREW HEAD, HE BELIEVES THAT HE MAY HAVE TORQUED THE DRIVER AND SNAPPED THE HEAD OFF THE SCREW IN THE DRIVER. A FRAGMENT OF THE IMPLANT IS REMAINING IN THE PATIENT - A SCREW SHANK IN C4 LATERAL MASS. NO ADDITIONAL SURGERY WAS REQUIRED AND AN ATTEMPT TO REMOVE THE IMPLANT WAS UNSUCCESSFUL. NO PATIENT SYMPTOMS WERE REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 21236341 ↗MalfunctionJan 25, 2025Break; Break
INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING SCREWS USED IN LAMINOPLASTY THERAPY. LEVELS IMPLANTED: 2 IT WAS REPORTED THAT THE SURGEON HAD FOLLOWED THE STEPS IN THE CENTERPIECE 2.0 SURGICAL TECHNIQUE BUT IT STILL RESULTED IN THE BREAKING OF 2 SCREWS DURING IMPLANTING. THE SCREWS HAVE BEEN EXPLANTED PARTIALLY AS THE SCREWS BROKE OFF AT NECK. THE SCREW THREADS ARE REMAINING IN THE PATIENT. PATIENT SYMPTOMS ARE UNKNOWN. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 21236316 ↗MalfunctionJan 23, 2025Break; Break
INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH A BONE SCREW USED IN LAMINOPLASTY WITH CENTERPIECE 2.0. NORMAL TECHNIQUE FOR STENOSIS. IT WAS REPORTED THE THREE CENTERPIECE SCREWS BROKE AND ONE OF WHICH HCP WAS UNABLE TO RETRIEVE AND THEREFORE THE REMAINDER OF THE SCREW WAS LEFT IN THE PATIENT. LEVELS IMPLANTED WAS C4-C6. THERE WAS NO ADDITIONAL SURGERY NEEDED FROM THIS EVENT, AND THERE IS NO PLAN TO REMOVE THE BROKEN SCREW LEFT INSIDE THE PATIENT. THE PROCEDURE WAS DONE SUCCESSFULLY. BUT THERE WAS A SMALL DELAY IN THE PROCEDURE WHEN TRYING TO RETRIEVE ONE OF THE SCREWS. THIS DELAY MIGHT HAVE LASTED FOR APPROXIMATELY 20 SECONDS. NO ADVERSE EVENT OCCURRED TO PATIENT. THERE WERE NO FURTHER COMPLICATIONS THAT WERE REPORTED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 21215665 ↗
Other Medtronic Sofamor Danek, Inc. products
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- CD HORIZON SOLERA VOYAGER Spinal System60 models · 411 reports
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- INFINITY Occipitocervical Upper Thoracic System35 models · 63 reports · 5 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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