NA 388.509Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10705034773339), received between Mar 21, 2017 and Sep 10, 2020 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2020Break; Break

  THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING THE SAME INSTRUMENT SINCE IT STILL FUNCTIONED EVEN THOUGH THE SCREW SHEARED OFF. THE LEAF SPRING WAS NOT DISPLACED DURING USE, IT WAS DISPLACED AFTER REPROCESSING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10514863 ↗
• MalfunctionApr 19, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2019, THE TWO (2) ROD INTRODUCTION PLIERS FOR DUAL-OPENING IMPLANTS WOULD NOT LOAD OR HOLD THE COLLARS. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR A ROD INTRODUCTION PLIERS. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8531229 ↗
• MalfunctionApr 19, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2019, THE TWO (2) ROD INTRODUCTION PLIERS FOR DUAL-OPENING IMPLANTS WOULD NOT LOAD OR HOLD THE COLLARS. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR A ROD INTRODUCTION PLIERS. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8531210 ↗
• MalfunctionFeb 15, 2019Device Difficult to Maintain; Device Difficult to Maintain

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING A PRE-OPERATIVE PROCEDURE, THE ROD INTRODUCTION PLIERS FOR DUAL-OPENING IMPLANT WERE UNABLE TO HOLD COLLARS WHEN TRYING TO LOAD THEM ONTO THE INSTRUMENT BEFORE STARTING A CASE. TWO TECHS TRIED MULTIPLE TIMES WITH MULTIPLE COLLARS AND WERE NOT SUCCESSFUL IN LOADING THE COLLARS TO EITHER OF THE PERSUADERS. THERE WERE NO REPORTS OF INJURY, MEDICAL INTERVENTION AND NO PROLONGED HOSPITALIZATION. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR ONE (1) ROD INTRODUCTION PLIERS FOR DUAL-OPENING IMPL F/6.0MM RODS. THIS REPORT IS 2 OF 3 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8345202 ↗
• MalfunctionFeb 15, 2019Device-Device Incompatibility; Device Difficult to Maintain; Device-Device Incompatibility; Device Difficult to Maintain

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING A PRE-OPERATIVE PROCEDURE, THE ROD INTRODUCTION PLIERS FOR DUAL-OPENING IMPLANT WERE UNABLE TO HOLD COLLARS WHEN TRYING TO LOAD THEM ONTO THE INSTRUMENT BEFORE STARTING A CASE. TWO TECHS TRIED MULTIPLE TIMES WITH MULTIPLE COLLARS AND WERE NOT SUCCESSFUL IN LOADING THE COLLARS TO EITHER OF THE PERSUADERS. THERE WERE NO REPORTS OF INJURY, MEDICAL INTERVENTION AND NO PROLONGED HOSPITALIZATION. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR ONE (1) ROD INTRODUCTION PLIERS FOR DUAL-OPENING IMPL F/6.0MM RODS. THIS REPORT IS 1 OF 3 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8345176 ↗
• MalfunctionFeb 4, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE TWO (2) ROD INTRODUCTION PLIERS FOR DUAL-OPENING WOULD NOT ENGAGE TO HOLD THE UNKNOWN COLLARS WHEN TRYING TO LOAD THE INSTRUMENT BEFORE STARTING A CASE. THE COLLAR KEPT FALLING OFF THE PERSUADER AFTER TRYING TO LOAD IT. THE TWO TECHNICIANS TRIED HARD MULTIPLE TIMES WITH MULTIPLE COLLARS AND WERE NOT SUCCESSFUL IN LOADING ANY COLLARS TO EITHER OF THE PERSUADERS. THERE WAS NO PATIENT INVOLVEMENT SINCE IT WAS DISCOVERED BEFORE STARTING THE CASE. CONCOMITANT MEDICAL PRODUCTS REPORTED: UNKNOWN COLLARS (PART#: UNKNOWN, LOT#: UNKNOWN, QUANTITY#: UNKNOWN). THIS REPORT IS FOR ONE (1) ROD INTRODUCTION PLIERS FOR DUAL-OPENING IMPL. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8303146 ↗
• MalfunctionFeb 4, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE TWO (2) ROD INTRODUCTION PLIERS FOR DUAL-OPENING WOULD NOT ENGAGE TO HOLD THE UNKNOWN COLLARS WHEN TRYING TO LOAD THE INSTRUMENT BEFORE STARTING A CASE. THE COLLAR KEPT FALLING OFF THE PERSUADER AFTER TRYING TO LOAD IT. THE TWO TECHNICIANS TRIED HARD MULTIPLE TIMES WITH MULTIPLE COLLARS AND WERE NOT SUCCESSFUL IN LOADING ANY COLLARS TO EITHER OF THE PERSUADERS. THERE WAS NO PATIENT INVOLVEMENT SINCE IT WAS DISCOVERED BEFORE STARTING THE CASE. CONCOMITANT DEVICE REPORTED: UNKNOWN COLLARS (PART#: UNKNOWN, LOT#: UNKNOWN, QUANTITY#: UNKNOWN). THIS REPORT IS FOR ONE (1) ROD INTRODUCTION PLIERS FOR DUAL-OPENING IMPL. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8303139 ↗
• MalfunctionFeb 1, 2019Loose or Intermittent Connection; Detachment of Device or Device Component; Naturally Worn; Loose or Intermittent Connection; Detachment of Device or Device Component; Naturally Worn

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING A ROUTINE INSPECTION OF CONSIGNMENT INSTRUMENT SETS, THE ROD INTRODUCTION PLIERS FOR DUAL-OPENING IMPLANTS RATCHET CAME OFF AND COULD NOT BE PUT BACK ONTO THE INSTRUMENT. THE TWO PARTS OF THE DEPTH GAUGE FOR PEDICLE SCREWS CAME APART AND WOULD NOT ATTACH AGAIN. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) ROD INTRODUCTION PLIERS FOR DUAL-OPENING IMPL F/6.0MM RODS THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8297785 ↗
• MalfunctionNov 21, 2018Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING ROUTINE INCOMING RECEIVING INSPECTION THE ROD INTRODUCTION PLIERS FOR DUAL OPENING WAS FOUND BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR PC-(B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8096710 ↗
• MalfunctionJul 11, 2018Break; Break

  IT WAS REPORTED THAT DURING ROUTINE INSPECTION ON (B)(6) 2018, IT WAS DISCOVERED THAT THERE WERE MALFUNCTIONS ON FIVE (5) DIFFERENT INSTRUMENTS. THE TUBE OF TWO (2) ROD INTRODUCTION PLIERS FOR SIDE-OPENING IMPLANTS WERE DISCOVERED BENT AND THE COLLAR WOULD NOT FIT. IN ADDITION, IT WAS ALSO NOTED THAT THE SECURING PIN ON THE HANDLE FOR HOOK/SCREW HOLDER WAS STARTING TO COME OUT RESULTING TO NOT ACCEPTING THE HOLDER SCREW. THE ROD INTRODUCTION PLIERS FOR DUAL-OPENING IMPLANT WAS ALSO NOTED TO BE BROKEN OR CRACKED. AND THE THREADED HOLDING SLEEVE FOR POLYAXIAL SCREWS WAS ALSO FOUND STRIPPED AND DID NOT THREAD ON THE SCREW EASILY. THERE WAS NO PATIENT INVOLVEMENT. CONCOMITANT DEVICES REPORTED: UNKNOWN COLLAR (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1), UNKNOWN SCREW HOLDER (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1), UNKNOWN POLYAXIAL SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1) THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7678989 ↗
• MalfunctionMay 16, 2018Break; Device Operates Differently Than Expected; Break; Device Operates Differently Than Expected

  IT WAS REPORTED THAT DURING INSPECTION, IT WAS FOUND OUT THAT THE RATCHET LEVER OF THE ROD INTRODUCTION PLIERS WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION AVAILABLE AT THIS TIME. THIS COMPLAINT INVOLVES (1) DEVICE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7519965 ↗
• MalfunctionApr 11, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT ONE (1) TABLE TOP ROD CUTTER AND BENDER HAD A LOT OF RESISTANCE, CAUSING A ROD TO NOT PASS IN AND OUT THROUGH THE HOLES IN THE CUTTER, AND ONE (1) ROD INTRODUCTION PLIERS FOR DUAL-OPENING IMPLANTS FOR 6.0 MM RODS CAUSED THE SCRUB TECHNICIANS A HARD TIME LOADING AN IMPLANT ON IT DURING A SPINAL FUSION PROCEDURE ON (B)(6) 2018, AND SUBSEQUENTLY, THE HANDLE ON THE PLIERS FELL OFF AT AN UNKNOWN TIME. THE SCRUB TECHNICIANS WERE TRAINING A NEW RECRUIT DURING A SURGERY WHEN THEY LOADED AN UNKNOWN COLLAR ON THE PLIERS AND THE PLIERS DID NOT HOLD THE COLLAR AS INTENDED, GIVING THE SCRUB TECHNICIANS A HARD TIME. SUBSEQUENTLY, THE HANDLE ON THE PLIERS WAS FOUND TO HAVE FALLEN OFF AFTER CLEANING IN THE STERILE PROCESSING DEPARTMENT (SPD) AND IT IS UNKNOWN IF THE HANDLE FELL OFF DURING THE SURGERY OR DURING THE CLEANING PROCESS. ANOTHER SET OF PLIERS AND CUTTER/BENDER WERE AVAILABLE AT THE TIME OF THE SURGERY AND HENCE THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS REPORTED TO HAVE BEEN COMPLETED SUCCESSFULLY AND WITHOUT ANY COMPLICATIONS. THE PATIENT CONDITION WAS REPORTED TO HAVE BEEN STABLE. THIS COMPLAINT INVOLVES ONE (1) INSTRUMENTS. CONCOMITANT DEVICES REPORTED: UNKNO

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7424085 ↗
• MalfunctionSep 22, 2017Break; Material Fragmentation; Break; Material Fragmentation

  DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A LUMBAR DISCECTOMY AND FUSION ON (B)(6) 2017 USING THE USS (UNIVERSAL SPINAL SYSTEM), THE ROD INTRODUCTION PLIERS DEVICE WAS BEING USED TO SEAT THE USS COLLAR OVER THE SCREW AND TIGHTEN ONTO THE ROD. THIS DEVICE HAS A COLLET THAT SLIDES UP AND DOWN AND THE COLLET IS GENTLY TAPPED IN ORDER TO BRING DOWN A "SLEEVE CAP" (USS COLLAR) INTO POSITION. AS THE SURGEON IMPACTED IT, THIS COLLET (SLIDING PORTION) BROKE OFF. THE PART WAS MANUALLY RETRIEVED AND SURGERY WAS COMPLETED WITH A SECOND SIMILAR DEVICE. THERE WAS NO SURGICAL DELAY, AND NO REPORTED HARM TO THE PATIENT. THIS COMPLAINT INVOLVES ONE DEVICE. THIS REPORT IS FOR ONE (1) ROD INTRODUCTION PLIERS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6888649 ↗
• MalfunctionMar 21, 2017Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE AS THE SURGEON WAS PLACING THE ROD AND ATTACHING IT TO THE UNIVERSAL SPINE SYSTEM II (USSII) SCREW WITH THE APPROPRIATE TI COLLAR USING THE PLIERS, THE FLANGE ON THE SLEEVE BROKE OFF. FRAGMENTS WERE GENERATED FROM THE BROKEN DEVICE AND EASILY REMOVED WITHOUT ADDITIONAL INTERVENTION. THE SURGEON WAS ABLE TO ATTACH THE COLLAR DESPITE THE INSTRUMENT BREAKING. DURING FINAL TIGHTENING OF THE CONSTRUCT, TWO INSTRUMENTS, THE HEXAGONAL SCREWDRIVER AND WRENCH STRIPPED AND IT BECAME DIFFICULT TO TIGHTEN THE LOCKING WASHERS. THE SURGEON WAS ABLE TO USE A MALLET AND POSITION THE INSTRUMENTS IN ORDER TO COMPLETE THE FINAL TIGHTENING OF THE CONSTRUCT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY AND NO HARM TO THE PATIENT. CONCOMITANT MEDICAL PRODUCTS: UNKNOWN ROD (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1); USSII SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1); TI COLLAR (PART #UNKNOWN, LOT# UNKNOWN, QUANTITY, 1); LOCKING WASHER (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY, UNKNOWN). THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6421509 ↗