NA 396.395Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705034777511), received between Dec 13, 2016 and Dec 24, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 24, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED ON (B)(6) 2025, THE CASPAR PIN DISTRACTORS WILL NOT BEND. THERE WAS NO SURGICAL DELAY REPORTED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23888621 ↗
• MalfunctionDec 24, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED ON (B)(6) 2025, THE CASPAR PIN DISTRACTORS WILL NOT BEND. THERE WAS NO SURGICAL DELAY REPORTED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23888592 ↗
• MalfunctionJan 18, 2019Corroded; Mechanical Jam; Corroded; Mechanical Jam

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, A CERVICAL DISTRACTOR MOVING PARTS ARE STIFF AND MOST OF THE INSTRUMENT IS LOOKING RUSTY. THIS WAS FOUND IN MEDICAL DEVICE REPROCESSING DEPARTMENT (MDRD) WHICH WAS MARKED AS BROKEN. PATIENT INVOLVEMENT IS UNKNOWN. THIS REPORT IS FOR ONE (1) ADJUSTABLE CERVICAL DISTRACTOR-LEFT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8261817 ↗
• MalfunctionMar 31, 2017Break; Break

  IT WAS REPORTED THAT DURING A ROUTINE INSPECTION IT WAS DISCOVERED THAT ONE OF THE ARMS OF THE ADJUSTABLE CERVICAL DISTRACTOR-LEFT IS BROKEN OFF. THE INSTRUMENT WAS FOUND IN A REPAIR BIN WITH NO OTHER INFORMATION. THERE WAS NO REPORT OF KNOWN PATIENT OR PROCEDURAL INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6449760 ↗
• MalfunctionDec 13, 2016Break; Break

  IT WAS REPORTED THAT A THREADED HOLDING SLEEVE FOR POLYAXIAL SCREWS WAS NOT THREADING PROPERLY DUE TO BEING WORN OUT FROM USE AND THE METAL OF AN ADJUSTABLE CERVICAL DISTRACTOR-LEFT, WAS CRACKED AT THE JOINT ¿ WHERE DEVICE PIVOTS ¿ MAKING IT LOOSE AT THE JOINT. THESE ISSUES WERE DISCOVERED DURING INSTRUMENT SET CHECKS. NO CASE OR PATIENT INVOLVEMENT. DURING THE MANUFACTURER SERVICE EVALUATION PROCESS IT WAS IDENTIFIED THAT ONE OF THE HINGE JOINTS OF THE RETURNED ADJUSTABLE CERVICAL DISTRACTOR WAS FROZEN AND WOULD NOT MOVE AND THE OTHER HINGE JOINT WAS BROKEN. THIS CONDITION WAS RE-EVALUATED AND DETERMINED TO BE REPORTABLE ON DECEMBER 2, 2016. CONCOMITANT DEVICE REPORTED: UNKNOWN POLYAXIAL SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY ONE). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6169726 ↗