Matrix 03.632.003Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10705034718682), received between Jul 13, 2018 and Nov 27, 2023 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 27, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON NOV 2, 2023 DURING AN UNKNOWN CASE THE DRIVERS HAD STRIPED. SURGERY WAS COMPLETED WITHOUT ANY SURGICAL DELAY. THIS REPORT IS FOR ONE (1) T25 STARDRV SHAFT F/MATRX CANUL/STANDARD THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18211907 ↗
• MalfunctionFeb 1, 2023Material Integrity Problem; Material Integrity Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16279506 ↗
• MalfunctionFeb 1, 2023Material Integrity Problem; Material Integrity Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16279505 ↗
• MalfunctionOct 4, 2019Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, THE SURGEON WAS PERFORMING A MATRIX MIS SPINAL FUSION AND UPON COMPLETION NOTICED THAT THE STANDARD T25 SCREWDRIVER SHAFTS NEEDED TO BE REPLACED. THEY WERE STRIPPED AT THE DISTAL END TIP. THE CASE WAS COMPLETED WITHOUT DELAY AND NO PATIENT INCIDENT OCCURRED, THEREFORE NO PATIENT INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) SCRDRIVERSHAFT T25 CANN STD. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9157079 ↗
• MalfunctionOct 4, 2019Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(4) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, THE SURGEON WAS PERFORMING A MATRIX MIS SPINAL FUSION AND UPON COMPLETION NOTICED THAT THE STANDARD T25 SCREWDRIVER SHAFTS NEEDED TO BE REPLACED. THEY WERE STRIPPED AT THE DISTAL END TIP. THE CASE WAS COMPLETED WITHOUT DELAY AND NO PATIENT INCIDENT OCCURRED, THEREFORE NO PATIENT INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) SCRDRIVERSHAFT T25 CANN STD. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9157070 ↗
• MalfunctionFeb 12, 2019Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT UNDERWENT A MATRIX MIS (MINIMALLY INVASIVE SURGERY) SPINAL FUSION PROCEDURE ON (B)(6) 2019. IT WAS FOUND OUT THAT FOUR (4) SCREWDRIVERS WERE ALL SUFFERING FROM NORMAL WEAR AND TEAR. THERE WAS NO SURGICAL DELAY. PROCEDURE OUTCOME IS UNKNOWN. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) T25 STARDRIVE SHAFT F/MATRIX CANNULATED/STANDARD. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8333650 ↗
• MalfunctionFeb 12, 2019Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT UNDERWENT A MATRIX MIS (MINIMALLY INVASIVE SURGERY) SPINAL FUSION PROCEDURE ON (B)(6) 2019. IT WAS FOUND OUT THAT FOUR (4) SCREWDRIVERS WERE ALL SUFFERING FROM NORMAL WEAR AND TEAR. THERE WAS NO SURGICAL DELAY. PROCEDURE OUTCOME IS UNKNOWN. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) T25 STARDRIVE SHAFT F/MATRIX CANNULATED/STANDARD. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8333642 ↗
• MalfunctionJan 7, 2019Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM (B)(4) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2018, A PATIENT UNDERWENT A POSTERIOR LUMBAR SPINAL FUSION USING THE MATRIX MINIMALLY INVASIVE SURGERY (MIS) SYSTEM. DURING THE PROCEDURE, ONE (1) T25 STARDRIVE SHAFT STANDARD AND ONE (1) RETAINING SLEEVE STANDARD WERE STRIPPED. NOTHING FELL INTO THE PATIENT. OTHER INSTRUMENTS FROM THE MATRIX MIS SYSTEM WERE USED TO COMPLETE THE PROCEDURE. PROCEDURE OUTCOME IS UNKNOWN. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A T25 STARDRIVE SHAFT FOR MATRIX.. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8222157 ↗
• MalfunctionSep 10, 2018Material Deformation; Material Deformation

  DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A MINIMALLY INVASIVE SPINE (MIS) FUSTION PROCEDURE ON (B)(6) 2018 UTILIZING MATRIX MIS SYSTEM, THE SURGEON NOTICED THAT THE SCREWS WERE POORLY INSERTING INTO THE PEDICLE. ONCE THE CASE WAS COMPLETED, THE SCRUB NURSE NOTICED THAT BOTH STANDARD AND LONG CANNULATED SCREWDRIVER SHAFTS WERE SLIGHTLY STRIPPED AND TWISTED AT THE DISTAL END TIP. THERE WAS NO DELAYED OBTAINED DURING SURGERY. THE SURGERY WAS COMPLETED WITH NO DELAY. PATIENT WAS NOT AFFECTED BY THIS DAMAGE. CONCOMITANT DEVICE REPORTED: LOCKING/SET SCREWS: MATRIX (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) STANDARD CANNULATED STARDRIVE SHAFT FOR MATRIX. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7862899 ↗
• MalfunctionJul 13, 2018Mechanical Problem; Mechanical Problem

  (B)(6) REPORTS THAT ON (B)(6) 2018, AS THE NURSE WAS SETTING UP THE TABLE FOR A POSTERIOR SPINAL FUSION SURGERY DONE MINIMALLY INVASIVE (MIS), THE SCREWDRIVER SHAFT WAS FOUND STRIPPED AT THE DISTAL END. THE NURSE SET ASIDE THE SCREWDRIVER AS OTHERS ARE PRESENT IN THE SET AND THE SURGERY WENT ON AS PLANNED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR A T25 STARDRIVE SHAFT F/MATRIX CANNULATED/STANDARD. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7687417 ↗