NA 314.152Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10886982188601), received between Feb 15, 2017 and Jan 22, 2026 — classified as 4 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (13 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 22, 2026Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT THE AO FITTING ON THE SCREW DRIVER SHAFTS ARE ALL DAMAGED AND PROVED DIFFICULT TO LOAD INTO THE AO COUPLING, ON OUT TORQUE LIMITER AND THE POWER TOOL BEING USED BY THE SURGICAL TEAM. THE DRILL BITS WORKED FINE IN BOTH COUPLINGS. THIS PROBABLY ADDED A 7 MINUTE DELAY TO THE CASE WHEN THEY WERE UNABLE TO REMOVE THE SHAFT FROM THE POWER TOOL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24147607 ↗
• MalfunctionDec 8, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THERE WAS DIFFICULTY GETTING THE SCREWDRIVER BITS INTO THE DRILL¿S QUICK-RELEASE COUPLING. THE VARIOUS DRILL BITS WE USED WENT INTO THE SAME COUPLING VERY EASILY; THE COUPLING IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23750342 ↗
• MalfunctionJul 23, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT REMOVAL SURGERY WITH THE SCREWDRIVER SHAFT AND THE EXTRACTION SCREW. THE HOSPITAL CONTACTED THE SALES REP TO SAY THAT WHEN THE SURGEON TRIED TO REMOVE THE DISTAL FEMORAL PLATE AND 5.0MM LOCKING SCREW THAT HAD BEEN INSERTED IN 2011, THE SCREWDRIVER SHAFT DID NOT ENGAGE PROPERLY, AND THE SURGEON TRIED TO REMOVE THE LOCKING SCREW USING AN EXTRACTION SCREW, BUT THE EXTRACTION SCREW BROKE. THE SALES REP CHECKED THE HISTORY AGAIN AND CALLED THE SURGEON CHECKED TO TELL HIM THAT THE CORRECT EXTRACTION INSTRUMENT HAD BEEN ARRANGED, BUT BY THAT TIME THE HEADS OF ALL SEVEN LOCKING SCREWS HAD ALREADY BEEN DRILLED OUT WITH A CARBIDE DRILL. ALL THE PLATES AND SCREWS HAD BEEN SUCCESSFULLY REMOVED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22577100 ↗
• MalfunctionJul 9, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT A REMOVAL SURGERY OF FOREIGN BODIES FROM BONES FOR HUMERUS SHAFT FRACTURE ON HUMERUS WITH THE PRODUCT IN QUESTION. IN THE SURGERY, THE PRODUCT IN QUESTION DID NOT FIT THE SCREW HEAD, SO 309-530 (EXTRACTION SCREW 4.5/5.0/6.5MM) WAS USED TO REMOVE THE SCREW. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THE SALES REP HAS RECEIVED A REQUEST TO INVESTIGATE WHETHER THERE WERE ANY PROBLEMS WITH THE PRODUCT IN QUESTION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22459370 ↗
• MalfunctionMay 2, 2024Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT A REMOVAL SURGERY. WHEN THE SCREWDRIVER SHAFT WAS CONNECTED TO THE SCREW THAT WAS TO BE REMOVED, THE SURGEON RECOGNIZED THERE WAS A PLAY INSIDE THE TIP OF THE SCREWDRIVER SHAFT, BUT CONTINUED REMOVAL. HOWEVER, THE SCREWDRIVER SHAFT WAS ABOUT TO IDLE, AND THE SURGEON HAD DIFFICULTY REMOVING THE SCREW. WHEN THE TIP OF THE SCREWDRIVER SHAFT WAS CHECKED, IT APPEARED TO BE WORN AND TWISTED. THE SURGEON CONTINUING TO USE THAT SCREWDRIVER SHAFT AND FINISHED THE REMOVAL WITH A HOSPITAL-OWNED SCREWDRIVER. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. THERE WERE NO PATIENT CONSEQUENCE NO SIGNS, SYMPTOMS OR PATIENT INVOLVEMENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) 3.5MM HEXAGONAL SCREWDRIVER SHAFT SELF-RETAINING THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19230402 ↗
• MalfunctionJan 16, 2024Break; Device-Device Incompatibility; Material Deformation; Break; Device-Device Incompatibility; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON DECEMBER 22, 2023, THE PATIENT UNDERWENT AN UNKNOWN SURGERY WITH A PROXIMAL TIBIA PLATE. THE SCREWDRIVER SHAFT COULD NOT BE CONNECTED TO AN AO CHUCK WHEN IT WAS USED TO INSERT A LOCKING SCREW WITH A POWER TOOL. THEREFORE, THE SCREW WAS INSERTED USING A JACOBS CHUCK. THE CONNECTION PART OF THE SCREWDRIVER SHAFT SEEMS TO BE CRASHED AND SLIGHTLY FLATTENED. THE SURGERY WAS COMPLETED ,WITHOUT ANY PROBLEMS, BY USING ALTERNATIVE TECHNIQUES. THERE WAS NO SURGICAL DELAY. THE PATIENT WAS REPORTED AS STABLE. THIS REPORT INVOLVES ONE (1) 3.5MM HEXAGONAL SCREWDRIVER SHAFT SELF-RETAINING. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18516641 ↗
• MalfunctionOct 17, 2023Break; Break

  IT WAS REPORTED THAT ON SEP 28, 2023, THE ITEM WAS CHIPPED OR DAMAGED AND WAS NO LONGER FUNCTIONAL. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 3.5 HEX SCRDRIVER SFT SELF-RETAINING. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17949237 ↗
• MalfunctionJul 24, 2023Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT UNDERWENT OPEN REDUCTION/INTERNAL FIXATION SURGERY FOR A DISTAL FEMORAL FRACTURE ON AN UNKNOWN DATE. ON (B)(6) 2023, EXTRACTION SURGERY WAS PERFORMED FOR AN UNKNOWN REASON. DURING THE SURGERY, THE EXTRACTION SCREW WAS BROKEN. A SCREWDRIVER COULD HAVE STRIPPED THE SCREW, SO AN EXTRACTION SCREW WAS USED, WHICH IMMEDIATELY BROKE OFF. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY DELAY. THE PATIENT OUTCOME WAS REPORTED TO BE STABLE. THE SURGEON CONFIRMED BY X-RAY THAT THERE WERE NO PIECES LEFT IN THE PATIENT. THIS REPORT INVOLVES ONE 3.5MM HEXAGONAL SCREWDRIVER SHAFT SELF-RETAINING. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17378227 ↗
• MalfunctionJun 28, 2023Break; Material Deformation; Break; Material Deformation

  THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17219996 ↗
• MalfunctionMay 25, 2023Break; Break

  DEVICE REPORT FROM DEPUY SYNTHESE REPORTS AN EVENT IN ITALY AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE DEVICES WERE DISCOVERED BROKEN. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) SCRDRIVERSHAFT-3.5-HEX SELF-HOLDING. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17007382 ↗
• MalfunctionMay 25, 2023Break; Break

  DEVICE REPORT FROM DEPUY SYNTHESE REPORTS AN EVENT IN ITALY AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE DEVICES WERE DISCOVERED BROKEN. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) SCRDRIVERSHAFT-3.5-HEX SELF-HOLDING. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17007379 ↗
• MalfunctionFeb 17, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6), 2022, THE PATIENT UNDERWENT THE REMOVAL SURGERY OF THE TOMOFIX PLATE FOR THE PROXIMAL TIBIA. DURING THE SURGERY, THE SURGEON COULD NOT REMOVE THE SCREWS WITH THE SCREWDRIVER. THE SURGEON REPLACED THE HANDLE WITH A T-HANDLE WHICH BELONGED TO THE HOSPITAL AND TRIED TO REMOVE THE SCREWS, BUT THE HEAD OF THE SCREWS STRIPPED. THE SURGEON USED THE EXTRACTION SCREW; HOWEVER, THE TIP OF THE EXTRACTION SCREW BROKE. THE SURGEON WAS ABLE TO REMOVE THE SCREWS BY CHIPPING THE HEAD OF THE SCREWS WITH THE CARBIDE DRILL AND CUT OFF FROM THE PLATE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. NO FRAGMENTS REMAIN IN THE PATIENT. THE PATIENT WAS REPORTED AS STABLE. THIS REPORT INVOLVES ONE (1) 3.5MM HEXAGONAL SCREWDRIVER SHAFT SELF-RETAINING. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13552337 ↗
• MalfunctionFeb 10, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT THE REMOVAL SURGERY WITH THE SCREWDRIVER SHAFT AND HANDLE. BEFORE THE DEVICE DELIVERY, THE AGENCY CONFIRMED THAT THE SCREWDRIVER SHAFT AND HANDLE WERE NOT CONNECTED PROPERLY AND WERE DISASSEMBLED EASILY. THE SURGERY WAS COMPLETED WITH NEW SET SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THE PATIENT OUTCOME WAS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) 3.5MM HEXAGONAL SCREWDRIVER SHAFT SELF-RETAINING. THIS IS REPORT 1 OF 2 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11310704 ↗
• MalfunctionAug 24, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020, THE REMOVAL SURGERY WAS APPLIED TO THE PATIENT WHO UNDERWENT THE SURGERY ON JUNE 19, 2019. DURING THE REMOVAL SURGERY, THE SURGEON KEPT FORCING THE DRIVER TO THE TWO (2) LOCKING SCREWS AT DISTAL END WHICH WERE LIKELY STUCK IN THE PLATE. THEN, THE TIP OF THE DRIVER SHAFT GOT BROKEN AND WAS LEFT IN THE LOCKING SCREW HEAD. THE OTHER LOCKING SCREWS WERE REMOVED SUCCESSFULLY. THE PLATE WAS REMOVED BUT BROKEN SCREWS ARE REMAINING IN THE PATIENT BODY. THE SURGERY WAS DELAYED 30 MINUTES. THE PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNK - DRILL BIT: (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 1); UNK - SCREWDRIVERS: SHAFTS (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 1). THIS COMPLAINT INVOLVES FOUR (4) DEVICES. THIS REPORT IS FOR (1) 3.5MM HEXAGONAL SCREWDRIVER SHAFT SELF-RETAINING. THIS IS REPORT 1 OF 3 (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10442843 ↗
• MalfunctionAug 7, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING THE USE OF THE KIT FZL100NS, IT WAS NOT POSSIBLE TO ENGAGE THE SCREWDRIVER 314.152 IN THE TORQUE LIMITER 511.771. AFTER THE PROCEDURE THE TORQUE LIMITER HAD BEEN TESTED AND IT WORKED WITH ANOTHER QUICK-LOCKING END CAPS. CONCOMITANT DEVICE: TORQUE LIMITER ,4.0NM FOR COMPACT AIR DRIVE AND POWER DRIVE (PART# 511.771; LOT# UNKNOWN; QUANTITY: 1). THIS REPORT IS FOR ONE (1) 3.5MM HEXAGONAL SCREWDRIVER SHAFT SELF-RETAINING. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10380421 ↗
• MalfunctionApr 8, 2020Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT HIGH TIBIAL OSTEOTOMY SURGERY FOR RIGHT KNEE OSTEOARTHRITIS. DURING THE SURGERY, THE SURGEON FOUND THAT THE TIP OF THE SCREWDRIVER SHAFT HAD BEEN DEFORMED AND COULD NOT BE USED. THE SURGEON INSERTED ALL SCREWS WITHOUT THE SCREWDRIVER. BONE FIXATION WAS NOT A PROBLEM. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A DELAY OF LESS THAN THIRTY (30) MINUTES. THIS REPORT IS FOR A 3.5MM HEXAGONAL SCREWDRIVER SHAFT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9939181 ↗
• MalfunctionJan 28, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A SCREWDRIVER SHAFT DID NOT FIT IN THE DRILL DUE TO A BURR. THERE WAS NO PATIENT IMPACT AS THERE WERE TWO SCREWDRIVERS IN THE SET. NO FURTHER INFORMATION IS PROVIDED. CONCOMITANT DEVICE REPORTED: POWERED DRIVERS/HANDPIECES: TRAUMA (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN). THIS REPORT IS FOR ONE (1) 3.5MM HEXAGONAL SCREWDRIVER SHAFT SELF-RETAINING. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9639096 ↗
• MalfunctionJan 28, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A SCREWDRIVER SHAFT DID NOT FIT IN THE DRILL DUE TO A BURR. THERE WAS NO PATIENT IMPACT AS THERE WERE TWO SCREWDRIVERS IN THE SET. NO FURTHER INFORMATION IS PROVIDED. CONCOMITANT DEVICE REPORTED: POWERED DRIVERS/ HANDPIECES: TRAUMA (PART # UNKNOWN; LOT # UNKNOWN; QUANTITY: UNKNOWN). THIS REPORT IS FOR ONE (1) 3.5MM HEXAGONAL SCREWDRIVER SHAFT SELF-RETAINING. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9638725 ↗
• InjuryNov 18, 2019Break; Break

  THE DEVICE THAT BROKE DURING THE SURGERY WAS NOT THE SCREWDRIVER SHAFT (314.152). THE BROKEN COMPLAINT PRODUCT IS NOT A DRIVER DESTINATION, "EXTRACTION SCREW 4.5 / 5.0 / 6.5MM (309-530)."

  Patient problems: No Code Available

  MAUDE report 9339295 ↗
• MalfunctionApr 17, 2019Device-Device Incompatibility; Device-Device Incompatibility

  CONCOMITANT DEVICE REPORTED: UNKNOWN HANDLE ( PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8523142 ↗
• InjuryApr 12, 2019Break; Break

  THERE ARE NO PIECES IN THE BODY AND THE DOCTOR CONFIRMED IT BY IMAGE DIAGNOSIS.

  Patient problems: No Code Available

  MAUDE report 8509456 ↗
• InjuryFeb 26, 2019Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT INITIALLY, PATIENT HAD AN UNKNOWN SURGERY USING A LOCKING COMPRESSION PLATE (LCP) DISTAL FIBULA PLATE ON (B)(6) 2017. ON (B)(6) 2019, PATIENT UNDERWENT A HARDWARE REMOVAL FOR UNKNOWN REASON. DURING REVISION, THE SURGEON COULD NOT UNTIGHTEN THE THREE (3) UNKNOWN SCREWS USING THE HEXAGONAL SCREWDRIVER SHAFT BECAUSE THE TIP OF SCREWDRIVER SHAFT WAS STRIPPED. THUS, THE SCREWS REMAINED IN THE PATIENT'S BODY. THE PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. CONCOMITANT DEVICES: LCP DISTAL FIBULA PLATE (PART UNKNOWN, LOT UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) SCREWDRIVER SHAFT. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 8371024 ↗
• MalfunctionJan 5, 2018Break; Break

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE INSTRUMENT BROKE SHORTLY AFTER PURCHASE. NO PATIENT INVOLVEMENT REPORTED. THIS REPORT IS FOR ONE (1) 3.5MM HEXAGONAL SCREWDRIVER SHAFT SELF-RETAINING. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7169862 ↗
• InjuryFeb 15, 2017Break; Break

  DEVICE REPORT FROM SYNTHES ON AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE REPORTED DEVICE WAS USED IN SURGERY ON (B)(6) 2017. IT WAS REPORTED THAT THE SURGEON SUCCESSFULLY EXTRACTED THE SCREW FROM (C) HOLE. HOWEVER, WHEN THE SURGEON TRIED TO EXTRACT FROM D HOLE, THE SCREW DRIVER SHAFT WAS BROKEN AND IT WAS LEFT INSIDE SCREW HEAD. THE SURGEON DECIDED TO LEAVE IT INSIDE THE BODY SINCE HE WAS ABLE TO REMOVE THE SCREWS. HOWEVER, IF HE HAD TRIED TO REMOVE THE (D) HOLE UNDER THE CIRCUMSTANCES, HE WOULD HAVE HAD TO DRILL A HEAD, TAKE OUT ALL THE OTHER SCREWS, AND TEAR OFF THE PLATE. BECAUSE THE SURGEON THOUGHT THOSE ARE BURDEN ON THE PATIENT, THE SURGEON LEFT IT AS IT WAS AND COMPLETED SURGERY. THIS COMPLAINT INVOLVES 2 PARTS. THERE IS NO INFORMATION AVAILABLE ABOUT PATIENT AND SURGICAL OUTCOME. THERE WAS NO SURGICAL PROLONGATION REPORTED. THE DRIVER TIP IS INSIDE THE BODY BUT THE STATUS OF THE PATIENT IS GOOD. NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED. CONCOMITANT DEVICES: 1X UNK LCP-PLT 5 HOLE PLATE. THIS REPORT IS 1 OF 2 FOR (B)(4).

  Patient problems: Device Embedded In Tissue or Plaque; No Code Available

  MAUDE report 6334575 ↗