NA 03.614.017Recalls & reported problems

Summary

The FDA's MAUDE database contains 72 adverse event reports that list this exact device (DI 10705034714882), received between Apr 4, 2017 and Nov 29, 2023 — classified as 72 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (41 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 25 most recent of 72 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 29, 2023Compatibility Problem; Material Integrity Problem; Compatibility Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN ISRAEL AS FOLLOWS: IT WAS REPORTED ON (B)(6), 2023, THAT DURING A POSTERIOR CERVICAL SURGERY WITH "SYNAPS" SET THE THREE ITEMS DID NOT WORK PROPERLY EVEN THOUGH THE SURGEON FOLLOWED THE TECHNIQUE CORRECTLY. SKU ROD INTRODUCT-NSTR DISINTEGRATED SEVERAL TIMES DURING USE. SKU HOLD-SL FAILED TO CONNECT TO THE SCREW PROPERLY AND IT APPEARS TO BE WORN AT ITS END. SKU BEND-PLIER F/R Ø3.5 IT WAS NOT POSSIBLE TO BEND THE ROD AS EXPECTED ACCORDING TO THE SURGEON. THERE WAS NO UNUSUAL USE OF THE PRODUCT AND THESE ARE PRODUCTS THAT BELONG TO A SET THAT THE SURGEON HAS BEEN USING FOR YEARS IN THIS HOSPITAL AND IN OTHER HOSPITALS. SKU HOLD-SL ACCORDING TO WHAT IS VISIBLE, IT APPEARS TO BE DUE TO NATURAL WEAR AND TEAR AND THE OTHER ITEMS HAVE AN UNKNOWN CAUSE. THIS IS A SENIOR SURGEON WHO KNOWS THE TECHNIQUE AND WAS PROPERLY INSTRUCTED. THE SURGEON OVERCAME THE INCIDENT BY USING ADDITIONAL PRODUCTS IN THE SET. THERE WAS NO SURGICAL DELAY DUE TO THE REPORTED EVENT. THERE WERE NO PATIENT OUTCOMES OR CONSEQUENCES. THIS REPORT IS FOR ONE (1) HOLD-SL THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18231705 ↗
• MalfunctionAug 4, 2023Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM GERMANY REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6), 2023, THERE WERE ISSUES WITH SEVERAL DEVICES. A RETAINING SLEEVE WITH THREAD: THE THREAD AT THE TIP OF THIS SCREWDRIVER SLEEVE WAS DEFECTIVE AND NO LONGER CORRECT. A SCREWDRIVER INSERT STARDRIVE T15: WHEN USING THE SCREWDRIVER INSERT AS A TORQUE SHAFT, IS DOES NOT WORK PROPERLY. A SPONGIOSA SCREW SYNAPSE D 4.5, LENGTH 36MM, FOR RODS 4.0: THE SCREW HEAD IS BROKEN OFF FROM THE BONE SCREW. THERE WAS NO PATIENT HARM. THIS REPORT IS FOR A THREADED HOLDING SLEEVE FOR POLYAXIAL SCREWS. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17460301 ↗
• MalfunctionJun 8, 2023Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM SYNTHES REPORTS, AN EVENT IN KUWAIT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, AFTER OPENING THE ITEM. THE SYNAPSE HOLD SL WAS NOT ALLOWING THE QUICK COUPLING STARDRIVE SYNAPSE SCREWDRIVER SHAFT TO INSERT IN. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE THREADED HOLDING SLEEVE FOR POLYAXIAL SCREWS. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17086014 ↗
• MalfunctionApr 26, 2023Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM THE UNITED KINGDOM REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2023, A SPRING ON A SYNAPSE SCREWDRIVER HOLDING SLEEVE BROKE WHEN LOADING A SCREW. A SECOND SCREWDRIVER FROM THE KIT WAS USED INSTEAD. PROCEDURE WAS COMPLETED WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A THREADED HOLDING SLEEVE FOR POLYAXIAL SCREWS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16815441 ↗
• MalfunctionFeb 21, 2023Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT THE OR STAFF INDICATED, THE THREADS FROM THE SYNAPSE HOLDING SLEEVES, THREADED WERE NOT ENGAGING SMOOTHLY WITH THE THREADS IN THE SCREWS. THERE WERE NO PATIENT CONSEQUENCE, OR SURGICAL DELAY. NO ADDITIONAL INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) THREADED HDNG SLV FOR POLYAXIAL SCREWS. THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16413986 ↗
• MalfunctionFeb 21, 2023Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT THE OR STAFF INDICATED, THE THREADS FROM THE SYNAPSE HOLDING SLEEVES, THREADED WERE NOT ENGAGING SMOOTHLY WITH THE THREADS IN THE SCREWS. THERE WERE NO PATIENT CONSEQUENCE, OR SURGICAL DELAY. NO ADDITIONAL INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) THREADED HDNG SLV FOR POLYAXIAL SCREWS. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16413920 ↗
• MalfunctionFeb 21, 2023Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT THE OR STAFF INDICATED, THE THREADS FROM THE SYNAPSE HOLDING SLEEVES, THREADED WERE NOT ENGAGING SMOOTHLY WITH THE THREADS IN THE SCREWS. THERE WERE NO PATIENT CONSEQUENCE, OR SURGICAL DELAY. NO ADDITIONAL INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) THREADED HDNG SLV FOR POLYAXIAL SCREWS. THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16413913 ↗
• MalfunctionFeb 7, 2023Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, THE HOLDING SLEEVE WAS FOUND TO BE NOT STRAIGHT WHEN THE SCREW WAS ATTACHED. A SECOND SET OF TOOLS WERE USED, AND THE HOLDING SLEEVE IN THE SECOND SET WAS STIFFER THAN USUAL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A THREADED HOLDING SLEEVE FOR POLYAXIAL SCREWS. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16311733 ↗
• MalfunctionFeb 7, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ONE OF THE TWO SETS OF THE HOLDING SLEEVE AND THE SCREWDRIVER SHAFT WAS NOT STRAIGHT WHEN THE SCREW WAS ATTACHED. THE OTHER SET WAS DIFFERENT FROM USUAL. ALTHOUGH THE THREADS FIT, IT WAS STIFF.THE PATIENT OUTCOME WAS REPORTED TO BE STABLE. NO OTHER MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16311727 ↗
• MalfunctionSep 22, 2022Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, DURING O-T FUSION (CERVICAL SPINE) FOR CERVICAL MYELOPATHY, THE SCREW IN QUESTION COULD NOT BE ATTACHED TO THE TWO SCREWDRIVERS IN QUESTION. THE OPERATION WAS COMPLETED SUCCESSFULLY USING ANOTHER SYNAPSE SCREWDRIVER. THERE WAS A DELAY OF APPROXIMATELY 30 MINUTES. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A THREADED HOLDING SLEEVE FOR POLYAXIAL SCREWS. THIS IS REPORT 3 OF 7 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15463452 ↗
• MalfunctionSep 22, 2022Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, DURING O-T FUSION (CERVICAL SPINE) FOR CERVICAL MYELOPATHY, THE SCREW IN QUESTION COULD NOT BE ATTACHED TO THE TWO SCREWDRIVERS IN QUESTION. THE OPERATION WAS COMPLETED SUCCESSFULLY USING ANOTHER SYNAPSE SCREWDRIVER. THERE WAS A DELAY OF APPROXIMATELY 30 MINUTES. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A THREADED HOLDING SLEEVE FOR POLYAXIAL SCREWS. THIS IS REPORT 2 OF 7 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15463423 ↗
• MalfunctionJan 31, 2022Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THE SYNAPSE SCREWDRIVER COULD NOT THREAD INTO THE SCREW-HEAD PROPERLY. THERE WAS NO CONSEQUENCE TO THE PATIENT. THIS REPORT IS FOR A SCREWDRIVER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13400496 ↗
• MalfunctionDec 27, 2021Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, IT WAS CONFIRMED THAT THE SLEEVE WAS BROKEN AT THE TIME OF DELIVERY. THE SLEEVE WAS NOT USED FOR ANY SURGERY AND HAS NO SURGICAL INFLUENCE. THIS REPORT IS FOR A SLEEVE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13087644 ↗
• MalfunctionJul 16, 2021Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 FOUR (4) SCREWS WERE DEPLOYED WITH THE SLEEVE WITHOUT ANY ISSUE. AFTER THE FIFTH SCREW WAS ATTACHED TO THE SLEEVE, THE SURGEON WAS NOT ABLE TO DETACH THE SCREW. THE PROCEDURE WAS COMPLETED WITH REPLACEMENTS. THIS REPORT IS FOR ONE (1) THREADED HOLDING SLEEVE FOR POLYAXIAL SCREWS. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12183564 ↗
• MalfunctionJul 16, 2021Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 FOUR (4) SCREWS WERE DEPLOYED WITH THE SLEEVE WITHOUT ANY ISSUE. AFTER THE FIFTH SCREW WAS ATTACHED TO THE SLEEVE, THE SURGEON WAS NOT ABLE TO DETACH THE SCREW. THE PROCEDURE WAS COMPLETED WITH REPLACEMENTS. THIS REPORT IS FOR ONE (1) THREADED HOLDING SLEEVE FOR POLYAXIAL SCREWS. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12183525 ↗
• MalfunctionJun 17, 2021Material Integrity Problem

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT THIS WAS A PCF IN THE CERVICAL SPINE TREATING CERVICAL CENTRUM FRACTURE ON (B)(6) 2021. THE SCRUB NURSE WAS NOT ABLE ATTACH THE HOLDING SLEEVE TO THE OUTER SLEEVE SMOOTHLY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) HOLD-SL. THIS REPORT IS 1 OF 2 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 12018114 ↗
• MalfunctionMay 21, 2021Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2021, THE PATIENT UNDERWENT FOR A SURGERY. DURING THE SURGERY, THE SURGEON WAS NOT ABLE TO CONNECT THE SCREWDRIVER TO A SCREW. ALSO, RATCHET MOVEMENT ON THE RATCHET HANDLE BECAME AWKWARD. THE SURGERY COMPLETED WITH 30-MINUTES DELAY. THE PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREW (PART # UNKNOWN; LOT # UNKNOWN; QUANTITY: 1). THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR (1)THREADED HOLDING SLEEVE FOR POLYAXIAL SCREWS. THIS REPORT IS 2 OF 2 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11867181 ↗
• MalfunctionSep 30, 2020Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING AN UNKNOWN CASE, THE FOUR (4) SCREWDRIVER SLEEVES' DISTAL END TIPS WERE SLIGHTLY DAMAGED (THE RINGS THAT ATTACHES TO THE SCREW). THIS IMPACTED THE ABILITY TO ATTACH THE SCREWDRIVERS TO THE SCREWS. THERE WAS NO PATIENT INVOLVEMENT AS THE NURSE IMMEDIATELY PUT THIS INSTRUMENTS ASIDE. CONCOMITANT DEVICE REPORTED: SCREW (PART#: UNKNOWN, LOT#: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR ONE (1) THREADED HOLDING SLEEVE FOR POLYAXIAL SCREWS. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10610411 ↗
• MalfunctionSep 30, 2020Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING AN UNKNOWN CASE, THE FOUR (4) SCREWDRIVER SLEEVES' DISTAL END TIPS WERE SLIGHTLY DAMAGED (THE RINGS THAT ATTACHES TO THE SCREW). THIS IMPACTED THE ABILITY TO ATTACH THE SCREWDRIVERS TO THE SCREWS. THERE WAS NO PATIENT INVOLVEMENT AS THE NURSE IMMEDIATELY PUT THIS INSTRUMENTS ASIDE. CONCOMITANT DEVICE REPORTED: SCREW (PART#: UNKNOWN, LOT#: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR ONE (1) THREADED HOLDING SLEEVE FOR POLYAXIAL SCREWS. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10610410 ↗
• MalfunctionSep 30, 2020Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING AN UNKNOWN CASE, THE 4 SCREWDRIVER SLEEVES' DISTAL END TIPS WERE SLIGHTLY DAMAGED (THE RINGS THAT ATTACHES TO THE SCREW). THIS IMPACTED THE ABILITY TO ATTACH THE SCREWDRIVERS TO THE SCREWS. THERE WAS NO PATIENT INVOLVEMENT AS THE NURSE IMMEDIATELY PUT THIS INSTRUMENTS ASIDE. CONCOMITANT DEVICE REPORTED: SCREW (PART#: UNKNOWN, LOT#: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR 1 THREADED HOLDING SLEEVE FOR POLYAXIAL SCREWS. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10610403 ↗
• MalfunctionSep 30, 2020Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING AN UNKNOWN CASE, THE FOUR (4) SCREWDRIVER SLEEVES' DISTAL END TIPS WERE SLIGHTLY DAMAGED (THE RINGS THAT ATTACHES TO THE SCREW). THIS IMPACTED THE ABILITY TO ATTACH THE SCREWDRIVERS TO THE SCREWS. THERE WAS NO PATIENT INVOLVEMENT AS THE NURSE IMMEDIATELY PUT THIS INSTRUMENTS ASIDE. CONCOMITANT DEVICE REPORTED: SCREW (PART#: UNKNOWN, LOT#: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR ONE (1) THREADED HOLDING SLEEVE FOR POLYAXIAL SCREWS. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10610396 ↗
• MalfunctionAug 9, 2020Mechanical Problem; Mechanical Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2020 THAT DURING AN UNKNOWN PROCEDURE, THE SPRING LOADED PORTION OF THE THREADED HOLDING SLEEVE CAME APART. THE DEVICE WAS ABLE TO BE REASSEMBLED PRIOR TO SURGERY BUT IT WAS REPORTED TO BE WEAKER THAN BEFORE. THE SURGERY WAS SUCCESSFULLY COMPLETED. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) THREADED HOLDING SLEEVE FOR POLYAXIAL SCREWS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10383305 ↗
• MalfunctionAug 7, 2020Mechanical Problem; Mechanical Problem

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT THE SCREW DRIVER CAME APART BEFORE THE PROCEDURE AND WAS SUCCESSFULLY PUT TOGETHER AGAIN BEFORE THE KNIFE WAS PUT TO SKIN. THERE WAS NO DISRUPTION TO THE PROCEDURE. THIS REPORT IS FOR ONE (1) THREADED HOLDING SLEEVE FOR POLYAXIAL SCREWS. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS REPORT IS LINKED TO (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10380281 ↗
• MalfunctionAug 7, 2020Mechanical Problem; Mechanical Problem

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT THE SCREW DRIVER CAME APART BEFORE THE PROCEDURE AND WAS SUCCESSFULLY PUT TOGETHER AGAIN BEFORE THE KNIFE WAS PUT TO SKIN. THERE WAS NO DISRUPTION TO THE PROCEDURE. THIS REPORT IS FOR ONE (1) THREADED HOLDING SLEEVE FOR POLYAXIAL SCREWS. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS REPORT IS LINKED TO (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10380132 ↗
• MalfunctionJul 16, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE THREADED HOLDING SLEEVE FOR POLYAXIAL SCREWDRIVER IS NOT CORRECTLY THREADING INTO SCREW TULIP. IT IS UNKNOWN IF THERE WERE PATIENT AND PROCEDURE INVOLVEMENT. CONCOMITANT DEVICES REPORTED: UNK - SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# UNKNOWN). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) THREADED HOLDING SLEEVE FOR POLYAXIAL SCREWS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10286137 ↗