NA 03.820.111Recalls & reported problems

Summary

The FDA's MAUDE database contains 57 adverse event reports that list this exact device (DI 10705034731520), received between Jul 16, 2018 and Feb 4, 2026 — classified as 2 injuries, 55 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (26 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, 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 25 most recent of 57 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 4, 2026Compatibility Problem

  IT WAS REPORTED THAT THE VERTEBRAL BODY RETAINERS ARE NOT STAYING LOCKED IN PLACE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24259001 ↗
• MalfunctionFeb 4, 2026Compatibility Problem

  IT WAS REPORTED THAT THE VERTEBRAL BODY RETAINERS ARE NOT STAYING LOCKED IN PLACE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24258998 ↗
• MalfunctionFeb 4, 2026Compatibility Problem

  IT WAS REPORTED THAT THE VERTEBRAL BODY RETAINERS ARE NOT STAYING LOCKED IN PLACE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24258993 ↗
• MalfunctionFeb 3, 2026Material Integrity Problem

  IT WAS REPORTED THE VERTEBRAL BODY RETAINER WAS BROKEN. THE THUMBSCREW ASSEMBLY FELL OUT AND ONE OF THE THUMBSCREW END CAP WAS BROKEN. THERE WAS REPORTEDLY NO HARM TO THE PATIENT AND NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24250703 ↗
• MalfunctionAug 20, 2025Mechanical Problem; Mechanical Problem

  ADDITIONAL INFORMATION RECEIVED: A. WHAT IS THE TIMING OF THE REPORTED EVENT? (PRE-OP, INTRA-OP, POST-OP). PRE OP AFTER STERILISATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22851373 ↗
• MalfunctionJul 10, 2025Use of Device Problem; Compatibility Problem; Use of Device Problem; Compatibility Problem

  IT WAS REPORTED THAT ON (B)(6) 2025 BY A DISTRIBUTOR THAT IN SURGERY A VERTEBRAL BODY RETAIN WAS MISSING THE BACK CAP ON ONE OF THE KEYS MAKING IT HARD TO KEEP THE KEY IN THE ARM. THE INSTRUMENT WAS RETURNED AND UPON VISUAL INSPECTION IT HAS BEEN NOTED THAT ON THE RIGHT ARM/LEG THE PIN AT THE UPPER JOINT IS BACKING OUT AND ON THE LEFT ARM/LEG THE PIN AT THE LOWER JOINT IS BACKING OUT. THERE WAS NO HARM TO THE PATIENT AND NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22469751 ↗
• MalfunctionJun 10, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE RIGHT ARM TOGGLE JUMPED FROM COMPRESSION TO NEUTRAL WHILE MOVING ALONG THE BAR. THERE WAS NO PATIENT HARM OR PROCEDURAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22174769 ↗
• MalfunctionJan 16, 2025Material Integrity Problem; Material Integrity Problem

  ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO PATIENT INVOLVEMENT AND NO BROKEN FRAGMENTS WERE RETAINED IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21170976 ↗
• MalfunctionOct 25, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT AFTER SENDING THE INSTRUMENT TO HOSPITAL, THE STAFF OF THE STERILE SUPPLY DEPARTMENT FOUND THAT THE MOVING ARM OF THE CASPER PIN DISTRACTOR DISINTEGRATED DUE TO SOME PARTS OF IT FALLING OFF. IT WAS THOUGHT THAT IT WAS BECAUSE THE WELDED POINT OF THAT PART WAS ABSENTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20536312 ↗
• MalfunctionOct 23, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2024, THE CONNECTING PIN HAS COME LOOSE. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20514040 ↗
• MalfunctionJul 15, 2024Use of Device Problem; Material Integrity Problem; Use of Device Problem; Material Integrity Problem

  IT WAS REPORTED DURING INSPECTION IT WAS NOTED THAT THE BACK RIGHT ARM IS MISSING THE CAP BEHIND THE GEAR KEY HOLE, THE TOP PIN ON THE RIGHT LEG IS STARTING TO COME OUT (THE WELD BROKE) AND THE KEY THAT WAS IN THE RIGHT ARM IS MISSING ITS END CAP ALLOWING THE GEAR KEY TO EASILY FALL OUT OF THE ARM WHICH ALLOWS THE ARM TO FREELY MOVE ALONG THE RACK. EVEN WITH THE GEAR KEY INSERTED INTO THE ARM THE RATCHETING MOTION WITHOUT THE GEAR KEY¿S END CAP IS NOT SMOOTH. IT IS UNKNOWN HOW OR WHEN THIS DAMAGE OCCURRED. THERE HAS BEEN NO REPORT OF PATIENT INVOLVEMENT OR HARM WITH REGARD TO THIS INSTRUMENT. THIS REPORT IS FOR A VERTEBRAL BODY RETAINER. THIS IS REPORT 1 OF 1 FOR (B)(4) .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19740998 ↗
• MalfunctionJul 8, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE SPREADER BROKE DURING THE OPERATION ON (B)(6) 2024. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) VERTEBRAL BODY RETAINER. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19693011 ↗
• MalfunctionJan 26, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON JANUARY 11 2024, THERE WAS PRODUCT DAMAGE. THE PRODUCT DAMAGE DOCUMENTED IN THIS PC HAS BEEN IDENTIFIED DURING LOAN KIT INSPECTION, BY THE LOAN KIT TECHNICIAN. THE EVENT DATE AND ALERT DATE ARE THE DATE THAT THE INSPECTION TOOK PLACE. THERE IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE. NO FURTHER INFORMATION CAN BE OBTAINED. THIS REPORT IS FOR ONE (1) VERTEBRAL BODY RETAINER THIS IS REPORT 5 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18586770 ↗
• MalfunctionJan 25, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON JANUARY 11 2024, THERE WAS PRODUCT DAMAGE. THE PRODUCT DAMAGE DOCUMENTED IN THIS PC HAS BEEN IDENTIFIED DURING LOAN KIT INSPECTION, BY THE LOAN KIT TECHNICIAN. THE EVENT DATE AND ALERT DATE ARE THE DATE THAT THE INSPECTION TOOK PLACE. THERE IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE. NO FURTHER INFORMATION CAN BE OBTAINED. THIS REPORT IS FOR ONE (1) VERTEBRAL BODY RETAINER THIS IS REPORT 4 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18580734 ↗
• MalfunctionJan 25, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON JANUARY 11 2024, THERE WAS PRODUCT DAMAGE. THE PRODUCT DAMAGE DOCUMENTED IN THIS PC HAS BEEN IDENTIFIED DURING LOAN KIT INSPECTION, BY THE LOAN KIT TECHNICIAN. THE EVENT DATE AND ALERT DATE ARE THE DATE THAT THE INSPECTION TOOK PLACE. THERE IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE. NO FURTHER INFORMATION CAN BE OBTAINED. THIS REPORT IS FOR ONE (1) VERTEBRAL BODY RETAINER. THIS IS REPORT 3 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18580713 ↗
• MalfunctionJan 25, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, THERE WAS PRODUCT DAMAGE. THE PRODUCT DAMAGE DOCUMENTED IN THIS PC HAS BEEN IDENTIFIED DURING LOAN KIT INSPECTION, BY THE LOAN KIT TECHNICIAN. THE EVENT DATE AND ALERT DATE ARE THE DATE THAT THE INSPECTION TOOK PLACE. THERE IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE. NO FURTHER INFORMATION CAN BE OBTAINED. THIS REPORT IS FOR ONE (1) VERTEBRAL BODY RETAINER THIS IS REPORT 2 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18580692 ↗
• MalfunctionJan 25, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON JANUARY 11 2024, THERE WAS PRODUCT DAMAGE. THE PRODUCT DAMAGE DOCUMENTED IN THIS PC HAS BEEN IDENTIFIED DURING LOAN KIT INSPECTION, BY THE LOAN KIT TECHNICIAN. THE EVENT DATE AND ALERT DATE ARE THE DATE THAT THE INSPECTION TOOK PLACE. THERE IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE. NO FURTHER INFORMATION CAN BE OBTAINED. THIS REPORT IS FOR ONE (1) VERTEBRAL BODY RETAINER. THIS IS REPORT 1 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18580657 ↗
• MalfunctionNov 21, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE REPORTER REQUESTED FOR THE REPLACEMENT OF THE VERTEBRAL BODY RETAINER BECAUSE THE SPRING IN ONE OF THE ARMS WAS BROKEN. THIS REPORT IS FOR ONE (1) VERTEBRAL BODY RETAINER. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18185481 ↗
• MalfunctionNov 21, 2023Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM AUSTRALIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON OCTOBER 31, 2023, A ZERO P-VA KIT WAS MISSING A PIN. THE KIT WAS PROVIDED WITH A SINGULAR VERTEBRAL BODY DISTRACTOR. THE DISTRACTOR WAS UNUSABLE AND ANOTHER, SIMILAR ONE WAS ABLE TO BE LOCATED TO COMPLETE THE CASE. THIS REPORT IS FOR A VERTEBRAL BODY RETAINER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18184881 ↗
• MalfunctionJul 18, 2023Mechanical Problem; Material Integrity Problem; Mechanical Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON (B)(6) 2023, ONE OF THE PINS FELL OUT OF THE RETAINING ARM POSTOPERATIVELY. THERE WAS NO PATIENT INVOLVEMENT. THE VERTEBRAL BODY RETAINER WAS REPORTED TO HAVE BROKEN IN THE STERILE PROCESSING DEPARTMENT AFTER THE CASE. THERE WAS NO SURGICAL DELAY, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT INVOLVES ONE VERTEBRAL BODY RETAINER. THIS IS REPORT 1 OF 1 FOR PC(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17342184 ↗
• MalfunctionApr 17, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON (B)(6) 2023, DURING THE CASE THE VERTEBRAL BODY RETAINER BROKE, THE ARM BROKE IN HALF AT THE 2ND JOINT. THERE WAS NO PATIENT HARM AND ONLY A SLIGHT PROCEDURAL DELAY WHILE THE INSTRUMENT WAS EXCHANGED FOR A ANOTHER FUNCTIONING ONE. THIS REPORT INVOLVES ONE (1) VERTEBRAL BODY RETAINER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16754973 ↗
• MalfunctionMar 15, 2023Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SWITZERLAND REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE SALES CONSULTANT WAS ADVISED OF BROKEN SPOT WELDING ON THE DISTRACTOR ARM. THE PIN WAS RESIDING IN ITS POSITION, BUT WAS LOOSE. THE PRODUCT WAS PART OF AN ACTIVE CLINICAL LOAN SET FROM THE SWISS SPINE SALES ORGANIZATION. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A VERTEBRAL BODY RETAINER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16546881 ↗
• MalfunctionFeb 16, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON (B)(6) 2023, THE RETAINER WAS OLD AND USED IN THE MEDICAL EDUCATION SETS. DURING USE IN A MEDED CADAVER LAB, THE PIN ON THE LEFT ARM BROKE OFF. SINCE THIS WAS A CADAVER LAB, THERE WAS NO ¿PATIENT¿ INVOLVEMENT, BUT IT WAS USED DURING ¿SURGERY¿. THERE WAS NO SURGICAL DELAY AND PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) VERTEBRAL BODY RETAINER THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16390388 ↗
• MalfunctionDec 6, 2022Mechanical Problem; Mechanical Problem

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN SWITZERLAND AS FOLLOWS: IT WAS REPORTED THAT INTRAOPERATIVELY ON AN UNKNOWN DATE IN 2022 THE DEVICE HAD A LOOSE PIN ON ONE OF THE DISTRACTOR ARMS. THE DISTRACTOR ARM WAS FIXED BY PUTTING A K-WIRE INSTEAD OF THE PIN. THE STERILIZATION DEPARTMENT FOUND THE MISSING/DEFECTIVE PIN IN THE STERILIZATION TRAY AFTER THE SURGERY. THERE WAS APPROXIMATE FIVE (5) MINUTES SURGICAL DELAY. THERE WAS NO PATIENT IMPACT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. DURING MANUFACTURER'S INVESTIGATION OF THE RETURNED DEVICE IT WAS IDENTIFIED THAT THE DOWEL PIN, PLACED ON THE RIGHT RETAINER ARM, WAS NOT FULLY SEATED, CAUSING LOOSENESS OF THE RETAINER ARM. THIS REPORT IS FOR ONE (1) VERTEBRAL BODY RETAINER THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15925287 ↗
• MalfunctionOct 4, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, THE PIN CAME OUT OF THE PRODISC C VERTEBRAL BODY DISTRACTOR DURING A CASE. THE ISSUE DID NOT RESULT IN A DELAY OR CAUSE A CONSEQUENCE TO THE PATIENT. THIS REPORT INVOLVES ONE VERTEBRAL BODY RETAINER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15537071 ↗