NA 03.505.004Recalls & reported problems

Summary

The FDA's MAUDE database contains 69 adverse event reports that list this exact device (DI 10887587013305), received between Sep 5, 2018 and Feb 18, 2026 — classified as 2 injuries, 67 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 69 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 18, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT REMOVAL SURGERY. WHEN IT WAS DELIVERED THE DAY BEFORE SURGERY, IT WAS DISCOVERED THAT THE TURNING HANDLE COULD NOT BE ATTACHED TO THE HANDLE. IT WAS CONFIRMED THAT ALTHOUGH THERE WERE TIMES WHEN IT WAS NOT POSSIBLE TO ATTACH IT, IT WAS NOT COMPLETELY IMPOSSIBLE TO ATTACH IT. AS A RESULT, ADDITIONAL ARRANGEMENTS WERE QUICKLY MADE. THERE WAS NO IMPACT ON THE SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24377676 ↗
• MalfunctionApr 25, 2025Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING PRODUCT TESTING AFTER THE SET CAME THROUGH THE WASH, IT WAS FOUND THAT THE GEARS IN THE GOLD HANDLE OF THE 90 SCREWDRIVER WERE GRINDING ALONG WITH THE INNER SHAFT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21909559 ↗
• MalfunctionApr 25, 2025Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING PRODUCT TESTING AFTER THE SET CAME THROUGH THE WASH, IT WAS FOUND THAT THE GEARS IN THE GOLD HANDLE OF THE 90 SCREWDRIVER WERE GRINDING ALONG WITH THE INNER SHAFT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21909557 ↗
• MalfunctionOct 15, 2024Contamination /Decontamination Problem; Device-Device Incompatibility; Contamination /Decontamination Problem; Device-Device Incompatibility

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024. THE MINIMALLY INVASIVE PLATE OSTEOSYNTHESIS (MIPO) SYSTEM DID NOT WORK PROPERLY IN SURGERY AND WAS STICKING. THE ASSISTANT, WHEN REVIEWING THE PIECES AFTER SURGERY, FOUND THAT THE MOVING PARTS WERE UNLUBRICATED AND WITH DRY BLOOD RESIDUES. AS THE SYSTEM CONTAINS TWO OF EACH ITEM, OTHER DEVICES WERE AVAILABLE FOR USE. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20450811 ↗
• MalfunctionNov 15, 2023Device-Device Incompatibility; Scratched Material; Device-Device Incompatibility; Scratched Material

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT PRIOR TO A PLATE REMOVAL SURGERY (SSRO) ON SEPTEMBER 25, 2023, OPERATION STAFF ASSEMBLED THE HANDLE BEFORE STERILIZATION, AND NOTICED A SCRATCH ON THE CONNECTION PART WITH THE SHAFT. ALTHOUGH THE STAFF TRIED TO ASSEMBLE THE DEVICE, IT WAS NOT ABLE TO BE ATTACHED PROPERLY BECAUSE OF THE SCRATCH. THE SALES REPRESENTATIVE ALSO CONFIRMED THE SCRATCH AND POOR CONNECTION OF THE DEVICE. THE SALES REPRESENTATIVE PREPARED THE CNT-5 SET INSTEAD OF THE DEVICE IN QUESTION FOR SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. UPON MANUFACTURER INVESTIGATION OF THE DEVICE, IT WAS DETERMINED THAT DISTAL TREADED TIP WAS DEFORMED AND EXHIBITS SCRATCHES THIS REPORT IS FOR (B)(4). FOR THE HAND DEVICE.

  Patient problems: Insufficient Information

  MAUDE report 18143009 ↗
• MalfunctionNov 15, 2023Device-Device Incompatibility; Scratched Material; Device-Device Incompatibility; Scratched Material

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT PRIOR TO A PLATE REMOVAL SURGERY (SSRO) ON (B)(6) 2023, OPERATION STAFF ASSEMBLED THE HANDLE BEFORE STERILIZATION, AND NOTICED A SCRATCH ON THE CONNECTION PART WITH THE SHAFT. ALTHOUGH THE STAFF TRIED TO ASSEMBLE THE DEVICE, IT WAS NOT ABLE TO BE ATTACHED PROPERLY BECAUSE OF THE SCRATCH. THE SALES REPRESENTATIVE ALSO CONFIRMED THE SCRATCH AND POOR CONNECTION OF THE DEVICE. THE SALES REPRESENTATIVE PREPARED THE CNT-5 SET INSTEAD OF THE DEVICE IN QUESTION FOR SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. UPON MANUFACTURER INVESTIGATION OF THE DEVICE, IT WAS DETERMINED THAT DISTAL TREADED TIP WAS DEFORMED AND EXHIBITS SCRATCHES. THIS REPORT IS FOR (B)(4) FOR THE HAND DEVICE.

  Patient problems: Insufficient Information

  MAUDE report 18142854 ↗
• MalfunctionDec 8, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, A DEFECT IN ENGAGEMENT BETWEEN DEVICES OCCURRED. WHEN THE DEVICES WERE CHECKED BEFORE WASHING AND STERILIZATION, THE DEVICES GOT DETACHED EASILY BECAUSE THE ENGAGEMENT BETWEEN THE HANDS AND TURNING HANDLES WAS LOOSE. THE DEVICES ARE UNABLE TO BE USED IN SURGERY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) HAND. THIS IS REPORT 2 OF 4 FOR COMPLAINT (B)(4)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15942506 ↗
• MalfunctionDec 8, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, A DEFECT IN ENGAGEMENT BETWEEN DEVICES OCCURRED. WHEN THE DEVICES WERE CHECKED BEFORE WASHING AND STERILIZATION, THE DEVICES GOT DETACHED EASILY BECAUSE THE ENGAGEMENT BETWEEN THE HANDS AND TURNING HANDLES WAS LOOSE. THE DEVICES ARE UNABLE TO BE USED IN SURGERY. THIS REPORT IS FOR ONE (1) HAND THIS IS REPORT 1 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15942475 ↗
• MalfunctionOct 11, 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 DRILL BITS STICK IN CONTACT WITH THE BONE AND BLOCK THE SYSTEM. IT NEGATIVELY AFFECTS THE PROCEDURE DUE TO INCREASED SURGICAL TIME. THERE WERE ALSO TWO DRILL BITS WITHOUT FIXED. THIS REPORT INVOLVES ONE (1) HANDLE FOR 90° SCREWDRIVER. THIS IS REPORT 2 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15580324 ↗
• MalfunctionOct 11, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE DRILL BITS STICK IN CONTACT WITH THE BONE AND BLOCK THE SYSTEM. IT NEGATIVELY AFFECTS THE PROCEDURE DUE TO INCREASED SURGICAL TIME. THERE WERE ALSO TWO DRILL BITS WITHOUT FIXED. THIS REPORT INVOLVES ONE (1) HANDLE FOR 90° SCREWDRIVER. THIS IS REPORT 1 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15580285 ↗
• MalfunctionAug 26, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE DEVICES IN QUESTION WERE FOUND UNABLE TO ROTATE PROPERLY. THERE IS NO REPORTED PATIENT INVOLVEMENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A HANDLE FOR 90° SCREWDRIVER. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15300678 ↗
• MalfunctionJul 29, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT THE HANDLE IN QUESTION IS INTENDED TO BE ATTACHED TO AN ELECTRIC DRIVER, HOWEVER THE LOCAL DISTRIBUTION COMPANY (B)(4) DOES NOT DEAL WITH ANY APPLICABLE ELECTRIC DRIVERS. (B)(4) DISTRIBUTION CENTERS DO NOT CONDUCT PRE-SHIPPING INSPECTION TO FIND OUT IF THE HANDLE IS FREE OF MALFUNCTION. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A HANDLE FOR 90° SCREWDRIVER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15134548 ↗
• InjuryMay 10, 2022Mechanical Problem; Mechanical Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT HANDLES DO NOT WORK, THEY FIND IT DIFFICULT TO TURN. IT HAS NEGATIVE IMPLICATIONS FOR THE PATIENT, ADDITIONAL 4 INCISIONS ARE MADE. THIS COMPLAINT INVOLVES ONE (1) DEVICE HAND. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 14348156 ↗
• MalfunctionMar 25, 2022Break; Break

  DEVICE REPORTED AS BROKEN AND REPAIRABLE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13906052 ↗
• MalfunctionJan 18, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE DEVICES WERE UNABLE TO CONNECT FIRMLY. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) HANDLE FOR 90° SCREWDRIVER THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13285417 ↗
• MalfunctionDec 9, 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, PATIENT UNDERWENT FOR A SURGICAL PROCEDURE. DURING THE SURGERY, WHEN PIERCING PIECE ASSEMBLED TO AIR PENG DOES NOT CONNECT. THE SURGERY WAS COMPLETED WITHOUT DELAY. THE PATIENT OUTCOME IS UNKNOWN. THIS COMPLAINT INVOLVES TWO(2) DEVICES. THIS REPORT IS FOR (1) HANDLE FOR 90° SCREWDRIVER. THIS IS REPORT 2 OF 2 OR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12969183 ↗
• MalfunctionOct 15, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT, THEY WERE UNABLE TO STERILIZE/ASSEMBLE THE GEAR NOT MATCHING OR WAS MALFUNCTIONING DURING STERILIZATION. NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) HANDLE FOR 90° SCREWDRIVER. THIS IS REPORT 2 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12642796 ↗
• MalfunctionJun 21, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2021, IN ORDER TO MAKE A BURR HOLE, THEY ASSEMBLED THE 90 DEGREE SCREWDRIVER COMPONENTS OUT OF A SCREWDRIVER KIT AND CONNECTED WITH A STRYKER¿S TPS (TOTAL PERFORMANCE SYSTEM). HOWEVER, THE STRYKER DID NOT START AND TRIED ASSEMBLING SPARE SCREWDRIVER COMPONENTS FROM THE SAME KIT, WHICH LEAD TO THE SAME RESULT. THEY TRIED ASSEMBLING THE DEVICE ONE MORE TIME AND IT WORKED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. CONCOMITANT DEVICE REPORTED. RCANEINSTR F/REMOVAL OF INSERTS (PRODUCT#: 05.505.003, LOT#: UNK, QUANTITY: 1). THIS COMPLAINT INVOLVES (8) DEVICES. THIS REPORT IS FOR (1) HANDLE FOR 90 SCREWDRIVER. THIS REPORT IS 1 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12031804 ↗
• MalfunctionJun 21, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2021, IN ORDER TO MAKE A BURR HOLE, THEY ASSEMBLED THE 90 DEGREE SCREWDRIVER COMPONENTS OUT OF A SCREWDRIVER KIT AND CONNECTED WITH A STRYKER¿S TPS (TOTAL PERFORMANCE SYSTEM). HOWEVER, THE STRYKER DID NOT START AND TRIED ASSEMBLING SPARE SCREWDRIVER COMPONENTS FROM THE SAME KIT, WHICH LEAD TO THE SAME RESULT. THEY TRIED ASSEMBLING THE DEVICE ONE MORE TIME AND IT WORKED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. CONCOMITANT DEVICE REPORTED. RCANEINSTR F/REMOVAL OF INSERTS (PRODUCT#: 05.505.003, LOT#: UNK, QUANTITY: 1). THIS COMPLAINT INVOLVES EIGHT (8) DEVICES. THIS REPORT IS FOR (1) HANDLE FOR 90 SCREWDRIVER. THIS REPORT IS 2 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12031800 ↗
• MalfunctionJun 15, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, WHEN USING 90 DEGREE SCREWDRIVER THE UNKNOWN SCREW WOULD NOT LOCK INTO UNKNOWN PLATE. THE HANDLE KEPT SPINNING AND WOULD NOT LOCK SCREW. A DIFFERENT 90 SCREWDRIVER WAS USED AND SCREW LOCKED INTO PLATE. NO FRAGMENTS GENERATED. THERE WERE 5 MINUTES SURGICA DELAY. THE PROCEDURE SUCCESSFULLY COMPLETED. NO PATIENT OUTCOME. CONCOMITANT DEVICE REPORTED: UNK - SCREW (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN), UNK - PLATE (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) HANDLE FOR 90 SCREWDRIVER. THIS REPORT IS 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12005290 ↗
• MalfunctionNov 24, 2020Device Slipped; Device-Device Incompatibility; Device Slipped; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING ASSEMBLY IN STERILIZATION PROCESSING DEPARTMENT (SPD) TO CHECK FOR GOOD OPERATION, THE 90-DEGREE SCREWDRIVER SHAFT AND 90-DEGREE SCREWDRIVER HANDLE WERE SLIPPING AND WILL NOT ADVANCE THE SCREW. THE 90-DEGREE SCREWDRIVER T-HANDLE WAS BROKEN AND TWO LITTLE METALS PIECES AT END ONE IS MISSING CAUSING THE DEVICE TO MALFUNCTION. THERE IS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES FIVE (5) DEVICES. THIS REPORT IS FOR (1) HANDLE FOR 90° SCREWDRIVER. THIS IS REPORT 2 OF 5 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10897435 ↗
• MalfunctionNov 24, 2020Device Slipped; Device-Device Incompatibility; Device Slipped; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING ASSEMBLY IN STERILIZATION PROCESSING DEPARTMENT (SPD) TO CHECK FOR GOOD OPERATION, THE 90-DEGREE SCREWDRIVER SHAFT AND 90-DEGREE SCREWDRIVER HANDLE WERE SLIPPING AND WILL NOT ADVANCE THE SCREW. THE 90-DEGREE SCREWDRIVER T-HANDLE WAS BROKEN AND TWO LITTLE METALS PIECES AT END ONE IS MISSING CAUSING THE DEVICE TO MALFUNCTION. THERE IS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES FIVE (5) DEVICES. THIS REPORT IS FOR (1) HANDLE FOR 90° SCREWDRIVER. THIS IS REPORT 5 OF 5 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10897328 ↗
• MalfunctionSep 29, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT SSRO PLATE REMOVAL SURGERY. DURING THE SURGERY, THE SURGEON ASSEMBLED THE SHAFT AND HANDLE AND USED THEM, BUT THEY WERE IDLING, AND THE SURGEON COULDN¿T TURN A SCREW. THE HOSPITAL HAD OTHER DEVICES AND STERILIZED THEM AND USED THEM. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH ONE HUNDRED AND TWENTY (120) MINUTES DELAY. PATIENT WAS STABLE FOLLOWING THE PROCEDURE. THIS REPORT IS FOR A HANDLE FOR 90° SCREWDRIVER. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10602609 ↗
• MalfunctionSep 24, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2020, AN INVENTORY CHECK OCCURRED AND MULTIPLE DEVICES INCLUDING A MESH CUTTER, RIGHT ANGLE BENDER, PLATE CUTTER, 90 DEGREE SCREWDRIVER T-HANDLE, HANDLE FOR 90° SCREWDRIVER, SHAFT FOR 90° SCREWDRIVER, AND MATRIXRIB SCREWDRIVER BLADE SELF-RETAINING F/90° SCREWDRIVER WERE FOUND WITH MALFUNCTIONS. WHEN TESTED, THE DEVICES WOULD NOT WORK PROPERLY; WOULD NOT TURN, HOLD SCREWS, AND SOME WERE STRIPPED. SOME INSTRUMENTS WERE BENT OR DULL. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT. THIS IS REPORT 6 OF 6 FOR (B)(4). THIS COMPLAINT IS LINKED TO (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10581783 ↗
• MalfunctionSep 24, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2020, AN INVENTORY CHECK OCCURRED AND MULTIPLE DEVICES INCLUDING A MESH CUTTER, RIGHT ANGLE BENDER, PLATE CUTTER, 90 DEGREE SCREWDRIVER T-HANDLE, HANDLE FOR 90° SCREWDRIVER, SHAFT FOR 90° SCREWDRIVER, AND MATRIXRIB SCREWDRIVER BLADE SELF-RETAINING F/90° SCREWDRIVER WERE FOUND WITH MALFUNCTIONS. WHEN TESTED, THE DEVICES WOULD NOT WORK PROPERLY; WOULD NOT TURN, HOLD SCREWS, AND SOME WERE STRIPPED. SOME INSTRUMENTS WERE BENT OR DULL. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT. THIS IS REPORT 5 OF 6 FOR (B)(4). THIS COMPLAINT IS LINKED TO (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10581734 ↗