NA 396.396Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10705034777528), received between Jan 4, 2017 and Dec 26, 2025 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (7 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 26, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT UPON INSPECTION OF THE INSTRUMENT IN STERILE PROCESSING, ONCE IT WAS RECEIVED THROUGH THE WASH, THE SALES REPRESENTATIVE DISCOVERED THE FIXED ARM ON THE DISTRACTOR HAD A SMALL PIECE BROKEN OFF OF IT. THE PIECE WAS RETAINED INSIDE OF ITS BOX AND RECOVERED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23896089 ↗
• MalfunctionDec 24, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED ON DECEMBER 09, 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 23888623 ↗
• 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 23888616 ↗
• MalfunctionJul 21, 2023Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT DURING AN ANTERIOR CERVICAL FUSION PROCEDURE ON (B)(6) 2023, AT THE TIME OF DECOMPRESSION, THE CONNECTION PART OF THE DEVICE BROKE APPROXIMATELY TWO HOURS AFTER THE START OF USING THE DEVICE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THE PATIENT OUTCOME WAS REPORTED TO BE STABLE. THIS REPORT INVOLVES ONE ADJUSTABLE CERVICAL DISTRACTOR-RIGHT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17371063 ↗
• MalfunctionNov 23, 2021Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THIS WAS AN ANTERIOR CERVICAL FUSION ON (B)(6) 2021. DURING THE SURGERY, THE CERVICAL DISTRACTOR BROKE. NO FRAGMENTS WERE GENERATED. THE SURGERY WAS COMPLETED USING ANOTHER CERVICAL DISTRACTOR WITHOUT ANY SURGICAL DELAY. THE PATIENT OUTCOME WAS STABLE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) ADJUSTABLE CERVICAL DISTRACTOR-RIGHT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12863794 ↗
• MalfunctionAug 13, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE ADJUSTABLE CERVICAL DISTRACTOR RIGHT WAS BROKEN. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY. THE PROCEDURE OUTCOME WAS UNKNOWN. THE PATIENT WAS NO HARM. THIS REPORT IS FOR ONE (1) ADJUSTABLE CERVICAL DISTRACTOR-RIGHT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12318062 ↗
• MalfunctionJun 8, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, ABOUT A CERVICAL CAST FOR PIN DISTRACTOR IT IS COME APART, FALLS IN 2 PIECES IT WON'T STAY TOGETHER. IT WAS FIRST REPORTED 4/12. IT IS UNKNOWN IF THERE IS PATIENT AND SURGICAL INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11962871 ↗
• MalfunctionDec 1, 2020Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT DURING THE INSPECTION THE DISTRACTOR CAME A PART. IT WAS UNKNOWN HOW IT WAS HAPPENED. THERE WAS NO PROCEDURE AND PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) ADJUSTABLE CERVICAL DISTRACTOR-RIGHT THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10930930 ↗
• MalfunctionNov 30, 2020Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, WHEN DOING AN INSPECTION OF CONSIGNMENT INSTRUMENTS, THE ADJUSTABLE CERVICAL DISTRACTOR WAS BROKEN, AND IT IS UNKNOWN WHEN OUR HOW IT BROKE. IT IS A CERVICAL DISTRACTOR AND ONE OF THE ARMS BROKE OFF WHERE IT ARTICULATES. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) ADJUSTABLE CERVICAL DISTRACTOR-RIGHT. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10922665 ↗
• MalfunctionSep 28, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020, PATIENT UNDERWENT ANTERIOR CERVICAL FUSION PROCEDURE. DURING THE PROCEDURE THE ADJUSTABLE CERVICAL DISTRACTOR ARM BROKE OFF AT ITS WELD POINT WHILE REMOVING THE INSTRUMENT FROM THE DISTRACTION PINS AND WHILE PREPARING TO MOVE IT TO THE NEXT OPERATIVE LEVEL TO BE WORKED ON. THERE IS NO SURGICAL DELAY REPORTED. PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE IS NO PATIENT CONSEQUENCE REPORTED. CONCOMITANT DEVICE REPORTED: UNKNOWN DISTRACTION PINS (PART#: UNKNOWN, LOT#: UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) ADJUSTABLE CERVICAL DISTRACTOR-RIGHT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10593937 ↗
• MalfunctionJan 4, 2017Break; Break

  IT WAS REPORTED THAT AN ADJUSTABLE CERVICAL DISTRACTOR (RIGHT) WAS FOUND BROKEN. IT IS UNKNOWN WHEN THIS DEVICE BROKE. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6222870 ↗