NA 03.616.048Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10705034716381), received between Dec 12, 2016 and Oct 14, 2022 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Compatibility Problem” (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.

• MalfunctionOct 14, 2022Mechanical Problem; Compatibility Problem; Mechanical Problem; Compatibility Problem

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: IT WAS REPORTED THAT NO MATRIX MIS ROD CAN BE CORRECTLY ATTACHED/CONNECTED TO THE ROD HOLDER. IN ADDITION, THE ANGULATION OF THE ROD WITH THE HANDLE IS NO LONGER CONVERTIBLE. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) ROD INTRODUCER. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15607370 ↗
• MalfunctionMay 24, 2021Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE TIP OF THE ROD INTRODUCER HAS BROKEN OFF AND THE INSTRUMENT CANNOT HOLD ANY RODS ANYMORE. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT REPORTED. THIS REPORT IS FOR ONE (1) ROD INTRODUCER. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11870546 ↗
• MalfunctionJan 5, 2021Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020 THAT THE PATIENT UNDERWENT FOR PSF SURGERY USING THE MATRIX MIS SYSTEM. DURING THE SURGERY, IT WAS NOTICED THAT THE MIS ROD HOLDER WAS NOT HOLDING THE ROD PROPERLY. THE OTHER MATRIX MIS SYSTEM WAS OPENED IN ORDER TO REMOVE THE BROKEN INSTRUMENTS. THE SURGERY WAS COMPLETED AND THERE WERE NO CONSEQUENCES OF THE PATIENT. THIS COMPLAINT INVOLVES 1 DEVICE. THIS REPORT IS FOR (1) ROD INTRODUCER. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11120270 ↗
• MalfunctionDec 11, 2020Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, THE ROD INTRODUCER WAS UNABLE TO CONNECT WITH RODS FROM THE MATRIX SYSTEM. THE DEFECT WAS DETECTED DURING AN UNKNOWN SURGERY. THERE WAS A SURGICAL DELAY OF TEN MINUTES. THERE IS NO FURTHER INFORMATION AVAILABLE. CONCOMITANT DEVICE REPORTED: UNKNOWN ROD (PART#: UNKNOWN, LOT#: UNKNOWN, QUANTITY: UNKNOWN). THIS REPORT IS FOR ONE ROD INTRODUCER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10994154 ↗
• MalfunctionNov 30, 2020Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020 DURING A MATRIX MIS PROCEDURE, SEVERAL INSTRUMENTS WERE DAMAGED. TWO (2) ROD INTRODUCERS COULD NO LONGER PROPERLY HOLD THE RODS MAKING IT DIFFICULT FOR PATIENT INSERTION. THE SCREWDRIVER SHAFT WAS STRIPPED AT THE DISTAL END TIP. THE ROD PERSUADER COULD NO LONGER HOLD ITS POSITION ONCE ENGAGED. THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. THE PROCEDURE OUTCOME IS UNKNOWN. THIS REPORT IS FOR ONE (1) ROD INTRODUCER. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10923011 ↗
• MalfunctionNov 27, 2020Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020 DURING A MATRIX MIS PROCEDURE, SEVERAL INSTRUMENTS WERE DAMAGED. TWO (2) ROD INTRODUCERS COULD NO LONGER PROPERLY HOLD THE RODS MAKING IT DIFFICULT FOR PATIENT INSERTION. THE SCREWDRIVER SHAFT WAS STRIPPED AT THE DISTAL END TIP. THE ROD PERSUADER COULD NO LONGER HOLD ITS POSITION ONCE ENGAGED. THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. THE PROCEDURE OUTCOME IS UNKNOWN. THIS REPORT IS FOR ONE (1) ROD INTRODUCER. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10913994 ↗
• MalfunctionJul 20, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2020 THAT ON AN UNKNOWN DATE, A ROD INTRODUCER WAS UNABLE TO HOLD RODS. THERE WERE NO FURTHER DETAILS REPORTED. CONCOMITANT DEVICE REPORTED: UNKNOWN ROD (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# UNKNOWN). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) ROD INTRODUCER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10295445 ↗
• MalfunctionDec 17, 2019Device-Device Incompatibility; Device-Device Incompatibility

  FURTHER IT WAS REPORTED THAT THE ROD HOLDER IS NOT PROPERLY HOLDING THE ROD AND IS BECOMING PROBLEMATIC FOR THE SURGEONS WHO WOULD BE USING THE DEVICE. THE LOCK IS MALFUNCTIONING, THEREFORE THE HANDLE ON THE ROD HOLDER NEEDS TO BE ENGAGED IN ORDER TO FULLY SECURE THE ROD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9478931 ↗
• MalfunctionApr 5, 2017Failure To Adhere Or Bond; Failure To Adhere Or Bond

  (B)(6) REPORTED DURING A LUMBAR MINIMALLY INVASIVE SURGERY (MIS) FUSION AT UNKNOWN LEVELS ON (B)(6) 2017, WHILE SURGEON WAS ATTEMPTING TO INSERT THE SECOND ROD IT WAS NOTED THE ROD INTRODUCER WAS NOT HOLDING THE ROD PROPERLY. SURGEON WAS ABLE TO COMPLETE THE PROCEDURE SUCCESSFULLY UTILIZING THE DEVICE WITH NO DELAY AND NO HARM TO PATIENT CONCOMITANT MEDICAL PRODUCTS: ROD( PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) ROD INTRODUCER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6461808 ↗
• MalfunctionDec 12, 2016Failure To Adhere Or Bond; Failure To Adhere Or Bond

  IT WAS NOTED THAT THE DEVICE WAS UNUSED. WHEN THE DEVICE WAS BEING REVIEWED BY THE MANUFACTURER, IT WAS NOTED THAT THE PIVOT SCREW WAS MISSING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6165956 ↗