UNIPLATERecalls & reported problems across all models

We found 6 models of UNIPLATE by Depuy Spine, LLC in the FDA's device registry (GUDID). Together they are named in 56 adverse event reports in the FDA's MAUDE database, received between Dec 13, 2018 and Feb 19, 2026 — classified as 6 injuries, 50 malfunctions.

The most frequently reported specific device problem is “Calibration Problem” (24 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 UNIPLATE problems

UNIPLATE models

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

• UNIPLATE 289707000

  ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
  33 reports
• UNIPLATE 289706000

  DRIVER, PROSTHESIS
  16 reports
• UNIPLATE 189707014

  APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
  3 reports
• UNIPLATE 189706114

  APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
  2 reports
• UNIPLATE 189706112

  APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
  1 report
• UNIPLATE 289712000

  ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
  1 report

Recent UNIPLATE adverse event reports

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

• MalfunctionFeb 19, 2026Calibration Problem

  IT WAS REPORTED THE HANDLE DID NOT MEET SPECIFICATIONS FOR TORQUE TESTING. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24389026 ↗
• MalfunctionFeb 2, 2024Break; Break

  DEVICE REPORT FROM THE UNITED KINGDOM REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2024, THE TIP OF THE CAM LOCK FINAL TIGHTENER SNAPPED OF IN THE CAM LOCK OF THE PLATE; THE FRAGMENT WAS REMOVED. AN ALTERNATIVE DEVICE WAS AVAILABLE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A UNIPL CAM TGHTNR SHFT TRI-LOBE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18636033 ↗
• MalfunctionDec 26, 2023Calibration Problem; Calibration Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THE DEVICE WAS FOUND TO BE OUT OF TOLERANCE. NO PATIENT INVOLVEMENT. THIS REPORT IS FOR UNIPLATE CAM TGHTNR TORQ HNDL FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18394194 ↗
• MalfunctionNov 30, 2023Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2023 DURING INCOMING INSPECTION OF A LOANER SET, THE TORQUE HANDLE IN QUESTION WAS FOUND TO BE OUT OF SPECIFICATION. THE TORQUE WAS MEASURING HIGHER THAN INTENDED. THERE WAS NO REPORTED PATIENT OR PROCEDURE INVOLVEMENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM CAM TIGHTENER TORQUE HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18239172 ↗
• MalfunctionOct 12, 2023Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, IT WAS IDENTIFIED DURING LOAN KIT INSPECTION THAT THE DEVICE¿S TORQUE WAS TESTING HIGH. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS REPORT INVOLVES ONE UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM CAM TIGHTENER TORQUE HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17923787 ↗
• MalfunctionSep 5, 2023Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON (B)(6) 2023 DURING ROUTINE INCOMING INSPECTION OF A LOANER SET, IT WAS OBSERVED THAT THE TORQUE DEVICE WAS FOUND TO BE OUT OF SPECIFICATION. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT IS FOR A UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM CAM TIGHTENER TORQUE HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17682104 ↗
• MalfunctionAug 7, 2023Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON (B)(6) 2023, DURING ROUTINE INSPECTION OF A LOANER SET, IT WAS OBSERVED THAT THE UNIPLATE CAM TIGHTENER TORQUE HANDLE WAS FOUND TO BE OUT OF DRAWING SPECIFICATION. THE TORQUE TESTED HIGH. THERE WAS NO KNOWN PATIENT OR PROCEDURE INVOLVEMENT. THIS REPORT INVOLVES ONE UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM CAM TIGHTENER TORQUE HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17468782 ↗
• MalfunctionDec 12, 2022Material Deformation; Material Deformation

  NO IDEA IF DELAY TO SURGERY AS WE DON¿T KNOW WHEN IT OCCURRED. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15960195 ↗
• MalfunctionAug 19, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM THE UNITED KINGDOM REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING TRAINING ON JULY 21, 2022, THE TORQUE SCREW DRIVER WAS NOT CLICKING. THERE WAS NO PATIENT OR PROCEDURE IMPACT. THIS REPORT IS FOR A UNIPL CAM TGHTNR SHFT TRI-LOBE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15258957 ↗
• MalfunctionApr 15, 2022Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING ROUTINE INCOMING INSPECTION OF A LOANER SET, IT WAS OBSERVED THAT THE TORQUE HANDLE WAS FOUND TO BE OUT OF DRAWING SPECIFICATION. THE TORQUE TESTED HIGH. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS REPORT IS FOR ONE (1) UNIPLATE CAM TGHTNR TORQ HNDL. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14119631 ↗
• MalfunctionApr 1, 2022Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2022, TWO (2) UNIPLATE CAM TIGHTENER SHAFTS WERE FOUND TO BE WORN AND UNUSABLE. THERE WAS REPORTED NO DELAY TO A PROCEDURE. THIS REPORT IS FOR AN UNIPLATE CAM TIGHTENER SHAFT. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13978465 ↗
• MalfunctionApr 1, 2022Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2022, TWO UNIPLATE CAM TIGHTENER SHAFTS WERE FOUND TO BE WORN AND UNUSABLE. THERE WAS REPORTED NO DELAY TO A PROCEDURE. THIS REPORT IS FOR AN UNIPLATE CAM TIGHTENER SHAFT. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13978410 ↗
• MalfunctionMar 3, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, DURING AN UNKNOWN PROCEDURE, THE HEAD OF THE SHAFT WAS BROKEN. NO PATIENT CONSEQUENCE REPORTED. THIS REPORT IS FOR ONE (1) UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM CAM TIGHTENER SHAFT THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13659894 ↗
• MalfunctionFeb 14, 2022Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING ROUTINE INCOMING INSPECTION OF A LOANER SET, IT WAS OBSERVED THAT THE UNIPLATE CAM TGHTNR TORQ HNDL WAS FOUND TO BE OUT OF SPECIFICATION AND THE TORQUE TESTED HIGH. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS REPORT INVOLVES ONE (1) UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM CAM TIGHTENER TORQUE HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13525016 ↗
• MalfunctionFeb 14, 2022Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING ROUTINE INCOMING INSPECTION OF A LOANER SET, IT WAS OBSERVED THAT THE UNIPLATE CAM TGHTNR TORQ HNDL WAS FOUND TO BE OUT OF SPECIFICATION. THE TORQUE TESTED HIGH. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS REPORT INVOLVES ONE (1) UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM CAM TIGHTENER TORQUE HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13524963 ↗

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