Matrix 03.632.004Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10705034718699), received between Dec 19, 2016 and Oct 29, 2022 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Dull, Blunt” (5 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.

• MalfunctionOct 29, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SCREWDRIVERS BROKE. THERE WERE NO PATIENT CONSEQUENCES. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE T-HANDLE T25 STARDRIVE SHAFT F/MATRIX-STANDARD. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15696761 ↗
• MalfunctionSep 30, 2020Break; Material Integrity Problem; Break; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2020 AN L5 S1 SINGLE LEVEL FUSION WAS PERFORMED USING AN ORTHOKIT LOAN MATRIX SET. DURING THE SECOND SCREW INSERTION, THE TIP OF A SCREW DRIVER BROKE WITH THE FIRST 2 THREADS STRIPPING. DURING INSERTION OF THE THIRD SCREW THE HANDLE OF ANOTHER SCREWDRIVER BROKE CLEAN OFF. A 7 X50MM SCREW WHICH WAS BEING INSERTED WAS DISCARDED AS A SMALL CHARD OF METAL WAS SEEN HANGING FROM ITS HEAD. THE GENERATED SHARDS WERE REMOVED SUCCESSFULLY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 3). UNKNOWN T-HANDLE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10605589 ↗
• MalfunctionFeb 8, 2018Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED THAT THE SURGEON WAS NOT ABLE TO REMOVE MATRIX SCREWS WITH THE T-HANDLE BECAUSE THE HANDLE WAS TURNING FREELY FROM THE DRIVER SHAFT (SHOULD BE ONE SOLID PIECE) DURING A PROCEDURE ON (B)(6) 2018. MULTIPLE DRIVERS WERE AVAILABLE; THEREFORE, THE CASE CONTINUED WITHOUT TROUBLE OR SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH GOOD PATIENT OUTCOME. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7251583 ↗
• MalfunctionFeb 6, 2018Break; Device Operates Differently Than Expected; Break; Device Operates Differently Than Expected

  IT WAS REPORTED THAT, ON (B)(6) 2018, A REVISION SURGERY WAS PERFORMED. DURING THE SURGERY, THE TIP OF A T-SHAPED SCREWDRIVER BROKE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A 2-MINUTE-DELAY, AND THERE WAS NO ADVERSE CONSEQUENCE. THIS COMPLAINT INVOLVES ONE (1) DEVICE THIS REPORT IS FOR ONE (1) SCREWDRIVER HANDLE. (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7244660 ↗
• MalfunctionMar 20, 2017Dull, Blunt; Dull, Blunt

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2017, DURING A TRANSFORAMINAL POSTERIOR LUMBAR INTERBODY FUSION (TPLIF) WITH MATRIX SYSTEM AND MTF BONE IMPLANT, THE LAMINA SPREADER, WHICH WAS USED TO PERFORM THE DISCECTOMY AND DISTRACT THE WORKING AREA, WAS NOT HOLDING PROPERLY. THE SURGEON REQUESTED ANOTHER LAMINA SPREADER IN ORDER TO COMPLETE THE CASE. IT SEEMS LIKE THE HINGE DOES NOT HOLD AS WELL AS IT SHOULD. IN ADDITION, THE SURGEON WAS FINALIZING THE POSITION OF ONE (1) OF THE MATRIX SCREWS AND FOUND THAT THE T-HANDLE T25 STARDRIVE SHAFT FOR MATRIX-STANDARD WAS NOT WORKING PROPERLY. THE END OF THE DISTAL TIP OF THE SCREWDRIVER IS SLIGHTLY STRIPPED. NOTHING FELL INTO THE PATIENT. ANOTHER SAME/LIKE PRODUCT WAS USED. THERE WAS NO SURGICAL DELAY DURING THE PROCEDURE. THE PATIENT WAS REPORTED AS STABLE. CONCOMITANT DEVICES REPORTED: MATRIX SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1). THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6417821 ↗
• MalfunctionFeb 8, 2017Material Deformation; Material Deformation

  IT WAS REPORTED THAT A T-HANDLE T25 STARDRIVE SHAFT WAS STRIPPED AT THE TIP, THE SLEEVE THREADS OF A HOLDING SLEEVE-STANDARD WITH STOP FOR MATRIX WERE STRIPPED, THE TIP OF THE T-PAL TRIAL SPACER HAS BROKEN OFF, THE TIP OF THE T-PAL SPACER APPLICATOR HAS BROKEN OFF, AND THE SLAP HAMMER BROKE INTO (2) PIECES AT THE VERY LOWEST PART OF THE HAMMER. THIS WAS DISCOVERED DURING ROUTINE INSPECTION. THERE IS NO PATIENT OR CASE INVOLVED. THIS IS REPORT 1 OF 5 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6311818 ↗
• MalfunctionJan 16, 2017Break; Device Operates Differently Than Expected; Break; Device Operates Differently Than Expected

  THE SERVICE AND REPAIR (S&R) DEPARTMENT DOCUMENTED THAT SYNTHES EVALUATION EQUIPMENT OF T-HANDLE T25 STARDRIVE SHAFT F/MATRIX-STANDARD HAS A FUNCTIONAL ISSUE, UNSPECIFIED. THIS ISSUE WAS IDENTIFIED DURING INSPECTION ACTIVITIES OF THE EVALUATION SET. THERE WERE NO ISSUES REPORTED BY THE CUSTOMER. DEVICE RETURNED TO MANUFACTURER. UPON EXAMINATION, IT WAS FOUND THAT THE DISTAL TIP OF DEVICE WAS BROKEN AND MISSING. THIS REPORT IS FOR ONE (1) STARDRIVE SHAFT F/MATRIX-STANDARD. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6253932 ↗
• MalfunctionDec 19, 2016Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT UPON ROUTINE INSPECTION OF FIELD EQUIPMENT IT WAS DISCOVERED THAT THE TIPS ARE WORN OUT ON FOUR (4) T-HANDLE T25 STARDRIVE SHAFT SCREWDRIVERS. IN ADDITION, THE THREADS ON THE DISTAL END OF A SCREWDRIVER SLEEVE WERE FOUND TO BE BROKEN. THE BROKEN PIECE REMAINS SOMEWHAT ATTACHED TO THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT. THIS IS REPORT 4 OF 5 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6185086 ↗
• MalfunctionDec 19, 2016Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT UPON ROUTINE INSPECTION OF FIELD EQUIPMENT IT WAS DISCOVERED THAT THE TIPS ARE WORN OUT ON FOUR (4) T-HANDLE T25 STARDRIVE SHAFT SCREWDRIVERS. IN ADDITION, THE THREADS ON THE DISTAL END OF A SCREWDRIVER SLEEVE WERE FOUND TO BE BROKEN. THE BROKEN PIECE REMAINS SOMEWHAT ATTACHED TO THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT. THIS IS REPORT 3 OF 5 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6185075 ↗
• MalfunctionDec 19, 2016Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT UPON ROUTINE INSPECTION OF FIELD EQUIPMENT IT WAS DISCOVERED THAT THE TIPS ARE WORN OUT ON FOUR (4) T-HANDLE T25 STARDRIVE SHAFT SCREWDRIVERS. IN ADDITION, THE THREADS ON THE DISTAL END OF A SCREWDRIVER SLEEVE WERE FOUND TO BE BROKEN. THE BROKEN PIECE REMAINS SOMEWHAT ATTACHED TO THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT. THIS IS REPORT 2 OF 5 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6185060 ↗
• MalfunctionDec 19, 2016Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT UPON ROUTINE INSPECTION OF FIELD EQUIPMENT IT WAS DISCOVERED THAT THE TIPS ARE WORN OUT ON FOUR (4) T-HANDLE T25 STARDRIVE SHAFT SCREWDRIVERS. IN ADDITION, THE THREADS ON THE DISTAL END OF A SCREWDRIVER SLEEVE WERE FOUND TO BE BROKEN. THE BROKEN PIECE REMAINS SOMEWHAT ATTACHED TO THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT. THIS IS REPORT 1 OF 5 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6185026 ↗