NA 03.616.043Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10705034716343), received between Mar 19, 2018 and Jan 31, 2023 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 31, 2023Material Integrity Problem; Material Integrity Problem

  THIS REPORT IS RELATED TO (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16274788 ↗
• MalfunctionAug 24, 2022Compatibility Problem; Material Integrity Problem; Compatibility Problem; Material Integrity Problem

  IT WAS REPORTED ON (B)(6) 2022, THAT THE STRIPPED DRIVER SLEEVE THREADED AND IT WAS DIFFICULT IN ENGAGING HEAD OF SCREW. THERE WAS NO PATIENT INVOLVEMENT. CONCOMITANT DEVICE REPORTED: UNK. SCREWS: TRAUMA (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN). THIS REPORT IS FOR ONE (1) LOCKING HOLDING SLEEVE-LONG FOR MATRIX. THIS IS REPORT 2 OF 2 FOR COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15281980 ↗
• MalfunctionAug 24, 2022Compatibility Problem; Material Integrity Problem; Compatibility Problem; Material Integrity Problem

  IT WAS REPORTED ON (B)(6) 2022, THAT THE STRIPPED DRIVER SLEEVE THREADED AND IT WAS DIFFICULT IN ENGAGING HEAD OF SCREW. THERE WAS NO PATIENT INVOLVEMENT. CONCOMITANT DEVICE REPORTED: UNK - SCREWS: TRAUMA(PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN) THIS REPORT IS FOR ONE (1) LOCKING HOLDING SLEEVE-LONG FOR MATRIX. THIS IS REPORT 1 OF 2 FOR COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15281972 ↗
• MalfunctionAug 1, 2022Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN HONG KONG AS FOLLOWS: IT WAS REPORTED THAT THE PEDICLE SCREW DRIVER SLEEVE OF MATRIX DEGEN WAS FOUND DAMAGED AFTER PATIENT USED IN SPINE OPERATION. THERE IS NO FURTHER INFORMATION. THIS REPORT IS FOR ONE (1) RETAIN-SLEEVE LOCKING LONG. THIS IS REPORT 1 OF 1 FOR COMPLAINT: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15139285 ↗
• MalfunctionApr 29, 2019Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) PROCEDURE DUE TO COLLAPSE ON THE DISC SPACE ON (B)(6) 2019, THE TIP OF THE LONG LOCKING RETAINING SLEEVE WAS BROKEN AFTER AN UNKNOWN SCREW WAS INSERTED UPON CHECKING ON AN X-RAY. THE BROKEN FRAGMENT WAS SEEN ON THE SCREW HEAD BUT WAS EASILY REMOVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. PATIENT CONDITION WAS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) LOCKING HOLDING SLEEVE-LONG FOR MATRIX. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8560354 ↗
• MalfunctionMar 5, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, THE LOCKING HOLDING SLEEVE-LONG FOR MATRIX BROKE DURING SCREW INSERTION. FRAGMENTS WERE GENERATED AND REMOVED EASILY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8391102 ↗
• MalfunctionMar 19, 2018Break; Break

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED DURING A PROCEDURE FOR LUMBAR SPINAL CANAL STENOSIS AT T10-L4, ON (B)(6) 2018, THE TIP OF THE LOCKING HOLDING SLEEVE WAS BROKEN. ANOTHER OF THE SAME DEVICE WAS READILY AVAILABLE AND WAS USED TO COMPLETE THE PROCEDURE SAFELY WITH A DELAY OF APPROXIMATELY 5 MINUTES. NO ADVERSE CONSEQUENCE TO THE PATIENT WAS REPORTED. THIS REPORT IS FOR ONE (1) LOCKING HOLDING SLEEVE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7349684 ↗