Matrix 03.632.075Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10705034719191), received between Feb 7, 2017 and Oct 27, 2022 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Fitting Problem” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 27, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, DURING THE PROCEDURE, THE SCREWDRIVER STRIPPED WITH MINIMAL EFFORT. IT IS UNKNOWN IF THERE WAS ANY DELAY IN SURGERY CAUSED BY THIS EVENT. THERE WAS NO CONSEQUENCE TO THE PATIENT. NO FURTHER INFORMATION IS KNOWN. THIS REPORT INVOLVES ONE SPORT GRIP T25 STARDRIVE SHAFT F/MATRIX-LONG. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15681849 ↗
• MalfunctionOct 17, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, THE DRIVER TIP WAS STRIPPED. IT WAS NO LONGER SELF-RETAINING. THIS WAS DISCOVERED IN THE PRE-OPERATIVELY DURING INSPECTION. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE SPORT GRIP T25 STARDRIVE SHAFT F/MATRIX-LONG. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15619149 ↗
• MalfunctionJul 19, 2018Naturally Worn; Naturally Worn

  (B)(6) REPORTS THAT ON AN UNKNOWN DATE, THE TIP OF A SCREWDRIVER SHAFT BECAME WORN WITH AGE. IT WAS UNKNOWN IF THERE WAS A SURGICAL PROCEDURE AND PATIENT INVOLVEMENT. THIS REPORT IS FOR A SPORT GRIP T25 STARDRIVE SHAFT FOR MATRIX-LONG. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7704718 ↗
• InjuryAug 16, 2017Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT ON (B)(6) 2017, THE PATIENT UNDERWENT AN ANTERIOR LUMBAR INTERBODY FUSION (ALIF) REVISION AT L5-S1 DUE TO A NON-UNION. DURING THE REMOVAL OF ONE (1) UNKNOWN ANTEGRA PLATE, FOUR (4) UNKNOWN SCREWS AND ONE (1) UNKNOWN INTERBODY SPACER BONE GRAFT AT L5-S1, THE SURGEON WAS UNABLE TO LOOSEN/REMOVE THE SUPERIOR SCREWS FROM THE PLATE WITH A SPORT GRIP T25 STARDRIVE SHAFT FOR MATRIX-LONG AND STRIPPED THE DRIVER. THE SURGEON HAD TO BURR THE PLATE OFF BELOW THE SUPERIOR SCREWS. THE UPPER SCREWS AT L5 (WHICH WERE STRIPPED) AND THE SUPERIOR PORTION OF THE PLATE (ALL OF WHICH WERE UNABLE TO BE REMOVED) WERE LEFT INTACT/IMPLANTED AFTER THE LOWER THREE-FOURTHS OF THE PLATE WAS REMOVED WITH METAL CUTTING BURR. THE LOWER SCREWS AND UNKNOWN INTERBODY SPACER WERE ALSO REMOVED. THERE WAS A SURGICAL DELAY; HOWEVER THE AMOUNT OF TIME IS UNKNOWN. THE PATIENT WAS REVISED TO A COMPETITOR'S INTERBODY SPACER. THE EVENT DID NOT RESULT IN ANY ADVERSE CONSEQUENCE FOR THE PATIENT. PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT WAS INITIALLY IMPLANTED WITH THE UNKNOWN ANTEGRA PLATE, UNKNOWN SCREWS, AND AN UNKNOWN INTERBODY SPACER ON AN UNKNOWN DATE. THIS REPORT ADDRESSES THE INTRAOPERATIVE

  Patient problems: No Code Available

  MAUDE report 6796929 ↗
• MalfunctionFeb 7, 2017Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT A PATIENT WITH DEGENERATIVE DISC DISEASE UNDERWENT A POSTERIOR LATERAL FUSION AT L2-S1 ON (B)(6) 2016. WHILE THE SURGEON WAS ENGAGING THE LOCKING CAP INTO THE SCREW HEAD, THE LOCKING CAP FELL OFF OF THE STARDRIVE SHAFT. THE LOCKING CAP WAS PICKED UP WITH FORCEPS AND PLACED BACK ON THE STARDRIVE SHAFT AND THE SURGEON WAS ABLE TO ENGAGE THE LOCKING CAP WITH THE SCREW HEAD. THE SURGEON WENT ON TO PLACE A SECOND LOCKING CAP AND EXPERIENCED THE SAME ISSUE WITH THE LOCKING CAP FALLING OFF THE SAME STARDRIVE SHAFT. THE SECOND LOCKING CAP WAS PICKED UP WITH FORCEPS AND PLACED BACK ON THE STARDRIVE SHAFT AND THE SURGEON WAS ABLE TO ENGAGE THE LOCKING CAP WITH THE SCREW HEAD. ANOTHER STARDRIVE SHAFT WAS USED AND THE THIRD LOCKING CAP FELL OFF. THE SURGEON PICKED UP THE LOCKING CAP WITH FORCEPS AND PLACED IT BACK ON THE STARDRIVE SHAFT AND WAS ABLE TO ENGAGE THE LOCKING CAP WITH THE SCREW HEAD. ALL THREE (3) LOCKING CAPS WERE PLACED SUCCESSFULLY. DURING FINAL TIGHTENING OF THE LAST LOCKING CAP, THE STRAIGHT TIP DRIVER (TORQUE SHAFT) BROKE IN HALF. APPROXIMATELY 10MM OF THE SHAFT BROKE OFF. THE TIP STAYED IN THE LOCKING CAP WHEN IT BROKE. THE BROKEN TIP WAS RETRIEVED FROM

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6307571 ↗
• MalfunctionFeb 7, 2017Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT A PATIENT WITH DEGENERATIVE DISC DISEASE UNDERWENT A POSTERIOR LATERAL FUSION AT L2-S1 ON (B)(6) 2016. WHILE THE SURGEON WAS ENGAGING THE LOCKING CAP INTO THE SCREW HEAD, THE LOCKING CAP FELL OFF OF THE STARDRIVE SHAFT. THE LOCKING CAP WAS PICKED UP WITH FORCEPS AND PLACED BACK ON THE STARDRIVE SHAFT AND THE SURGEON WAS ABLE TO ENGAGE THE LOCKING CAP WITH THE SCREW HEAD. THE SURGEON WENT ON TO PLACE A SECOND LOCKING CAP AND EXPERIENCED THE SAME ISSUE WITH THE LOCKING CAP FALLING OFF THE SAME STARDRIVE SHAFT. THE SECOND LOCKING CAP WAS PICKED UP WITH FORCEPS AND PLACED BACK ON THE STARDRIVE SHAFT AND THE SURGEON WAS ABLE TO ENGAGE THE LOCKING CAP WITH THE SCREW HEAD. ANOTHER STARDRIVE SHAFT WAS USED AND THE THIRD LOCKING CAP FELL OFF. THE SURGEON PICKED UP THE LOCKING CAP WITH FORCEPS AND PLACED IT BACK ON THE STARDRIVE SHAFT AND WAS ABLE TO ENGAGE THE LOCKING CAP WITH THE SCREW HEAD. ALL THREE (3) LOCKING CAPS WERE PLACED SUCCESSFULLY. DURING FINAL TIGHTENING OF THE LAST LOCKING CAP, THE STRAIGHT TIP DRIVER (TORQUE SHAFT) BROKE IN HALF. APPROXIMATELY 10MM OF THE SHAFT BROKE OFF. THE TIP STAYED IN THE LOCKING CAP WHEN IT BROKE. THE BROKEN TIP WAS RETRIEVED FROM

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6307563 ↗