Matrix 04.632.640Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705034745527), received between Apr 5, 2017 and Jun 12, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 12, 2023Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THIS WAS AN INTERBODY FUSION (L3, LEFT) FOR STENOSIS ON (B)(6)2023. THE SURGEON INSERTED THE SCREW AND TRIED TO DETACH IT FROM THE HOLDING SLEEVE, BUT IT DID NOT COME OFF. THE SURGEON TRIED VARIOUS METHODS, BUT THE SCREW DID NOT COME OFF AT ALL. THE SALES REP ASKED THE SURGEON TO REMOVE THE SCREW ONCE. THEN, THE SURGEON INSERTED ANOTHER SCREW USING ANOTHER HOLDING SLEEVE. THE INSERTED SCREW WAS DETACHED FROM THE HOLDING SLEEVE WITH NO PROBLEM. THE DEFECTIVE HOLDING SLEEVE COULD NOT BE DETACHED FROM THE SCREW DURING SURGERY. WHEN THE SALES REP TRIED TO DETACH THE HOLDING SCREW FROM THE SCREW AFTER SURGERY, IT DID NOT COME OFF AT ALL WITH THE USUAL DETACHING METHOD, BUT THE SALE REP WAS FINALLY ABLE TO DETACH THEM BY REPEATED PULLING, ETC. AFTER SEVERAL ATTEMPTS TO DETACH AND ATTACH THE HOLDING SLEEVE AND THE SCREW, THE SCREW WOULD NOT COME OFF THE HOLDING SLEEVE ABOUT 1 OUT OF EVERY 3 TIMES. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) 6.0MM TI MATRIX POLYAX SCRW 40MM TH L. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17107494 ↗
• MalfunctionFeb 10, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING A POSTERIOR SPINAL FUSION A PREASSEMBLED MATRIX SCREW WAS BROKEN. FRAGMENTS WERE GENERATED AND WERE REMOVED EASILY. THERE WAS A SURGICAL DELAY OF FIFTEEN (15) MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR ONE 6.0MM TI MATRIX POLYAXIAL SCREW 40MM THREAD LENGTH. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9688765 ↗
• MalfunctionApr 5, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  DEVICE REPORT FROM CANADA REPORTED THE FOLLOWING EVENT: IT WAS REPORTED THAT SYNTHES RECEIVED A REPORT FROM THE (B)(6). (B)(4) REPORTED THAT THE MATRIX SCREW WHEEL HEAD PART CAME DETACHED IN THE PATIENT. THE SCREW WAS REMOVED AND REPLACED WITH ANOTHER ONE. NO FURTHER INFORMATION IS AVAILABLE FOR REPORTING. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 6460848 ↗