NA 03.820.112Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10705034731537), received between Dec 10, 2018 and Jul 29, 2025 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (6 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 29, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING A PROCEDURE, THE SURGEON TRIED TO DISTRACT THE VERTEBRAL BODY AND A PIECE OF THE DISTRACTOR BROKE. A NEW SET WAS NEEDED TO FINISH THE SURGERY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22643612 ↗
• MalfunctionJul 8, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THAT THERE WAS A BROKEN VERTEBRAL DISTRACTOR IN ONE OF SETS. THE MALFUNCTION WAS DISCOVERED AFTER SURGERY, NOT DURING SURGERY. AFTER PRESSING (SPREADING) THE VERTEBRAL BODY SPREADER, IT WOULD NOT BOUNCE BACK TO ITS ORIGINAL POSITION. THERE WAS NO INJURIES AND DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22437286 ↗
• MalfunctionSep 6, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON (B)(6) 2024 THE INSTRUMENT BROKE DURING A CASE. THERE WAS NO PATIENT IMPACT. THERE WAS NO SURGICAL DELAY. THIS REPORT IS FOR ONE (1) VERTEBRAL DISTRACTOR. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20159640 ↗
• MalfunctionMar 15, 2023Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN SINGAPORE AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SURGICAL TEAM NOTICED THE PRODISC C PARALLEL DISTRACTOR WAS STIFF AND UNABLE TO SPRING BACK TO ITS ORIGINAL RESTING POSITION DESPITE THE BACK LEVER BEING RELEASED. THIS DID NOT ALLOW THE INSTRUMENT TO FUNCTION AS INTENDED, SO IT WAS NOT USED DURING THE CASE. ANOTHER FUNCTIONAL PARALLEL DISTRACTOR WAS PROVIDED TO COMPLETE THE SURGERY. THIS REPORT IS FOR ONE (1) VERTEBRAL DISTRACTOR. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16549674 ↗
• MalfunctionJun 20, 2022Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE USA AS FOLLOWS: IT WAS REPORTED ON UNKNOWN DATE THAT, HE NEEDS A NEW CERVICAL, VERTEBRAL BODY DISTRACTOR TO BE SENT TO LOWTIDE ENTERPRISES, ALEXI IN SANTA CRUZ. ON THE CURRENT ONE, THE PIN HAS COME OUT OF. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. THIS COMPLAINT INVOLVES ONE (1) DEVICE VERTEBRAL DISTRACTOR. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14745671 ↗
• MalfunctionMar 20, 2022Compatibility Problem; Compatibility Problem

  IT WAS REPORTED THE VERTEBRAL DISTRACTOR WAS UN-ALIGNED AND WON'T LOCK. THIS REPORT IS FOR A VERTEBRAL DISTRACTOR. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13829301 ↗
• MalfunctionNov 24, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, TWO VERTEBRAL BODY RETAINER AND ONE VERTEBRAL DISTRACTOR WERE BROKEN. IT IS UNKNOWN WHEN AND WHERE THE ISSUE WAS DISCOVERED. IT IS UNKNOWN IF THERE IS PATIENT NOR PROCEDURE INVOLVEMENT. THIS REPORT IS FOR ONE (1) VERTEBRAL DISTRACTOR. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12870842 ↗
• MalfunctionAug 6, 2021Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, AFTER WASHING DURING INSPECTION FOR REASSEMBLY. IT WAS NOTED THAT THE END OF THE TIP OF THE VERTEBRAL DISTRACTOR IS BROKEN OFF. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) VERTEBRAL DISTRACTOR. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12287589 ↗
• MalfunctionDec 7, 2020Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON NOVEMBER 10, 2020, THE TIP OF THE VERTEBRAL DISTRACTOR BROKE OFF. IT WAS RECOVERED AND TOOK OUT OF THE PATIENT. IT IS UNKNOWN IF THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO SURGICAL DELAY REPORTED. THE PATIENT OUTCOME WAS UNKNOWN. THIS REPORT IS FOR ONE (1) VERTEBRAL DISTRACTOR. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10960631 ↗
• MalfunctionOct 11, 2019Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE A VERTEBRAL DISTRACTOR PRODISC C SPRING IS FALLING OUT OF 1 OUT OF THE 2 ARMS OF THE DEVICE. THE CAUSE OF THE SPRING ISSUE IS UNKNOWN AS THE INSTRUMENT WAS BELIEVED TO BE PART OF ACCEPTABLE CENTINEL STOCK. THE DISTRIBUTING PARTNER IDENTIFIED THE ISSUE UPON RECEIPT OF THE INSTRUMENT SET. THERE WAS NO SURGICAL PROCEDURE INVOLVED, SCHEDULED, OR AFFECTED BY THE PROBLEM. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) VERTEBRAL DISTRACTOR PRODISC C. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9178893 ↗
• MalfunctionDec 10, 2018Device Slipped; Device Slipped

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A PRODISC C VERTEBRAL BODY DISTRACTOR WAS STICKING AND DIFFICULT TO ARTICULATE. THE SPRINGS NO LONGER FORCE THIS INSTRUMENT TO BE CLOSED. APPLICATION OF INSTRUMENT LUBRICANT HAS NOT BEEN ABLE TO IMPROVE THE CONDITION OF THE INSTRUMENT. THERE APPEARS TO BE NO PHYSICAL DAMAGE TO THE INSTRUMENT AND THE LOCKING MECHANISM IS FUNCTIONING AS EXPECTED. THERE WAS NO PROCEDURE OR PATIENT INVOLVEMENT. UPON MANUFACTURER RECEIPT AND INSPECTION OF THE DEVICE, IT WAS DETERMINED THAT A COMPONENT PART WAS LOOSE. THIS REPORT IS FOR A VERTEBRAL DISTRACTOR. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8146286 ↗