NA 03.010.063Recalls & reported problems

Summary

The FDA's MAUDE database contains 91 adverse event reports that list this exact device (DI 10886982067371), received between Dec 27, 2016 and Sep 22, 2026 — classified as 11 injuries, 80 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (64 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 91 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Device-Device Incompatibility

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50862727 ↗
• MalfunctionFeb 20, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2026, THE PATIENT UNDERWENT ORIF SURGERY FOR PROXIMAL HUMERUS FRACTURES. DURING THE PROCEDURE, ONE DISTAL HOLE WAS DRILLED AND CONFIRMED BY IMAGING TO HAVE PASSED THROUGH THE NAIL HOLE. WHILE DRILLING ANOTHER HOLE, THE DRILL BIT INTERFERED WITH THE NAIL. ALTHOUGH RECOVERY METHODS SUCH AS LIGHTLY TAPPING WITH A PLASTIC HAMMER, CREATING A PILOT HOLE WITH A K-WIRE, AND MANUALLY FINE-TUNING THE SLEEVE WERE ATTEMPTED, THE DRILL BIT WOULD NOT PASS THROUGH THE NAIL. AS A RESULT, NO SCREW WAS INSERTED INTO THAT HOLE AND FIXATION WAS PERFORMED WITH ONE DISTAL LOCKING SCREW. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHIN A THIRTY (30) MINUTE DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24400984 ↗
• MalfunctionMay 19, 2025Device-Device Incompatibility; Device-Device Incompatibility

  USING LOAN HINDFOOT ARTHRODESIS NAIL SET, THE SLEEVE 02.010.063 APPEARED DAMAGED AND WOULD NOT ALLOW THE SCREW HEAD THROUGH IT. THE SURGERY WAS DELAYED 5 MINUTES AND IT WAS UNKNOWN IF THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22044677 ↗
• MalfunctionApr 17, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT DURING THE APPLICATION OF THE HINDFOOT ARTHRODESIS NAIL (HAN), THE SURGEON DID THE PROXIMAL SIGHTING TO PUT A LOCKING SCREW BUT AFTER SCREWING, HE COULD NOT REMOVE THE PROTECTIVE SLEEVE SO HE HAD TO FORCE IT OUT AND PULLED OUT THE SCREW HE HAD JUST INSTALLED. THE SALES REP REPORTED THAT THE PROTECT SLEEVE IS NO LONGER ROUND WITH FORCE OF USE.

  Patient problems: Insufficient Information

  MAUDE report 21855615 ↗
• MalfunctionMar 18, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED DURING THE CASE IT BECAME EVIDENT THAT THE 8MM SLEEVE HAD BEEN DAMAGED PREVIOUSLY AS THE SCREW HEAD WOULD NOT PASS OUT THE END OF IT. THIS IS FROM A LOAN SET. WE COMPLETED THE CASE FINE WITHOUT THE TARGETING TOOL. SURGERY WAS COMPLETED SUCCESSFULLY WITH A 2 MINUTE SURGICAL DELAY

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21634496 ↗
• MalfunctionMar 3, 2025Material Integrity Problem; Material Integrity Problem

  DEFECTIVE ITEM WAS DELIVERED TO THE HOSPITAL. THE ISSUE WAS NOTICED WHILE ASSEMBLING IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21508944 ↗
• MalfunctionJan 15, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THESE ITEMS WERE NOT WORKING PROPERLY. DRILL GUIDES AND T6 POWER SHAFT WERE BENT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21162380 ↗
• MalfunctionDec 6, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED, THAT THE SURGEON HAD AN ISSUE THREADING THE SUPRAPATELLAR EXTRACTION SCREW, DURING THE TIBIAL NAIL REVISION. UPON INSPECTION, AFTER REMOVAL, IT APPEARS THAT THE THREADS WERE DAMAGED. WHEN PUTTING IN THE NEW NAIL, THE SURGEON HAD A HARD TIME FITTING THE INNER SLEEVE IN THE 12MM/8MM PROTECTION SLEEVE. ANOTHER SET WAS OPENED AND THAT ONE WORKED FINE. THERE WAS A 20 MINUTES OF SURGICAL DELAY AND THE SURGERY WAS COMPLETED SUCCESSFULLY. NO OTHER MEDICAL INTERVENTION REQUIRED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20870903 ↗
• MalfunctionSep 18, 2024Device-Device Incompatibility; Device-Device Incompatibility

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT IT HAPPENED DURING POST-OP AND THERE WAS A PATIENT INVOLVEMENT. THE SURGEON WAS TRYING TO FIT THE SCREW THROUGH THE SLEEVE AND IT DID NOT VERY WELL. THE DAMAGE DID NOT HAPPEN WITHIN THAT CASE, BUT ONLY DISCOVERED.

  Patient problems: Insufficient Information

  MAUDE report 20250344 ↗
• MalfunctionJul 23, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT ORIF SURGERY FOR FRACTURE OF THE PROXIMAL HUMERUS ON PROXIMAL HUMERUS WITH THE PRODUCTS IN QUESTION. IN THE SURGERY, DURING THE DRILLING OF THE DISTAL LATERAL STOP, THE DRILL BITS IN QUESTION WERE NOT SHARP ENOUGH, ALTHOUGH THE PATIENT'S BONE QUALITY WAS ALSO A FACTOR. THE SLEEVE IN QUESTION WAS INSERTED AND DRILLED UNTIL IT CONTACTED THE BONE, AVOIDING THE SOFT TISSUE, BUT THE DRILL INTERFERED IN THE G-HOLE. THE IMAGE CONFIRMED THAT THE DRILL TIP REACHED INSIDE THE NAIL HOLE, SO WHEN THE DRILL TIP WAS LIGHTLY TAPPED WITH A HAMMER, THE DRILL TIP PASSED THROUGH THE HOLE. FINALLY, WHEN INSERTING THE END CAP IN QUESTION, THE END CAP WAS REINSERTED SEVERAL TIMES, BUT IT DID NOT ENGAGE PROPERLY, AND THE SURGEON DECIDED TO CLOSE THE WOUND WITH THE CAP ENGAGED AT AN ANGLE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A 30 MINUTES SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THIS REPORT IS FOR ONE (1) PROTECT SLEEVE 12/8 L188. THIS IS REPORT 3 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19811158 ↗
• MalfunctionJul 11, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT ORIF SURGERY WITH THE PRODUCTS IN QUESTION. THIS IS A REPORT OF INTRAOPERATIVE INTERFERENCE BETWEEN THE DRILL TIP AND THE INTRAMEDULLARY NAIL. DURING THE SURGERY, AFTER INSERTION OF AN INTRAMEDULLARY NAIL AND PROXIMAL FIXATION, DISTAL ANTEROLATERAL SCREW FIXATION WAS PERFORMED. DURING DISTAL POSTEROLATERAL SCREW FIXATION, THE DRILL TIP INTERFERED WITH THE INTRAMEDULLARY NAIL. AFTER INTERFERENCE, BECAUSE OF THE POSSIBILITY OF FORCE ON THE SLEEVE DUE TO SOFT TISSUE TENSION, A SMALL AMOUNT OF SKIN INCISION AND DEPLOYMENT WAS ADDED. ATTEMPTED TO DRILL AGAIN BUT AGAIN THERE WAS INTERFERENCE. THE SURGEON PULLED OUT THE DRILL AND TRIED TO DRILL A HOLE WITH A SMALLER 3.0 MM DIAMETER K-WIRE, BUT THE INTERFERENCE HAPPENED AGAIN. THE CONNECTION BETWEEN THE INTRAMEDULLARY NAIL AND THE HANDLE AND THE CONNECTION BETWEEN THE AIMING ARM AND THE INSERTION HANDLE WERE CHECKED AGAIN FOR LOOSENESS. THERE WAS NO INTERFERENCE DURING THE DRY CHECK BEFORE INSERTION. WHEN CHECKED FROM THE SIDE WITH THE SLEEVE IN PLACE, IT WAS CLEARLY OBSERVED THAT THE SLEEVE WAS DISPLACED BACKWARD. THE SURGEON CONSIDERED REMOVING THE AIMING ARM AND PERFORMING THE I

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19725975 ↗
• MalfunctionJul 11, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT ORIF SURGERY WITH THE PRODUCTS IN QUESTION. THIS IS A REPORT OF INTRAOPERATIVE INTERFERENCE BETWEEN THE DRILL TIP AND THE INTRAMEDULLARY NAIL. DURING THE SURGERY, AFTER INSERTION OF AN INTRAMEDULLARY NAIL AND PROXIMAL FIXATION, DISTAL ANTEROLATERAL SCREW FIXATION WAS PERFORMED. DURING DISTAL POSTEROLATERAL SCREW FIXATION, THE DRILL TIP INTERFERED WITH THE INTRAMEDULLARY NAIL. AFTER INTERFERENCE, BECAUSE OF THE POSSIBILITY OF FORCE ON THE SLEEVE DUE TO SOFT TISSUE TENSION, A SMALL AMOUNT OF SKIN INCISION AND DEPLOYMENT WAS ADDED. ATTEMPTED TO DRILL AGAIN BUT AGAIN THERE WAS INTERFERENCE. THE SURGEON PULLED OUT THE DRILL AND TRIED TO DRILL A HOLE WITH A SMALLER 3.0 MM DIAMETER K-WIRE, BUT THE INTERFERENCE HAPPENED AGAIN. THE CONNECTION BETWEEN THE INTRAMEDULLARY NAIL AND THE HANDLE AND THE CONNECTION BETWEEN THE AIMING ARM AND THE INSERTION HANDLE WERE CHECKED AGAIN FOR LOOSENESS. THERE WAS NO INTERFERENCE DURING THE DRY CHECK BEFORE INSERTION. WHEN CHECKED FROM THE SIDE WITH THE SLEEVE IN PLACE, IT WAS CLEARLY OBSERVED THAT THE SLEEVE WAS DISPLACED BACKWARD. THE SURGEON CONSIDERED REMOVING THE AIMING ARM AND PERFORMING THE I

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19725634 ↗
• MalfunctionMar 5, 2024Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT DURING SURGERY ON FEBRUARY 20, 2024, THE PROTECTION SLEEVE WAS WORN AND WAS NOT FITTING WELL THROUGH THE AIMING ARM. ONCE FITTED, IT WAS VERY HARD TO REMOVE. THERE WAS NO SURGICAL DELAY IN RELATION TO THE EVENT, AND THERE WAS NO HARM TO THE PATIENT. THIS REPORT INVOLVES ONE 12.0MM/8.0MM PROTECTION SLEEVE 188MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18838918 ↗
• MalfunctionMar 4, 2024Device-Device Incompatibility; Device-Device Incompatibility

  THIS REPORT IS FOR ONE (1) 12.0MM/8.0MM PROTECTION SLEEVE 188MM.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18826475 ↗
• MalfunctionFeb 22, 2024Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2024, A SLEEVE WAS DAMAGED. IT WAS BENT WHERE SCREW HEAD WOULD NOT FIT THRU THE SLEEVE. THERE WAS A MINOR SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) 12.0MM/8.0MM PROTECTION SLEEVE 188MM THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18759682 ↗
• MalfunctionFeb 12, 2024Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2024 THE PATIENT UNDERWENT AN ORIF SURGERY WITH MHN IMPLANTS FOR A FRACTURE OF THE LEFT PROXIMAL HUMERUS. THE SURGEON USED A DRILL SLEEVE FOR THE DISTAL WHEN HE DRILLED THE PROXIMAL AP HOLE. GAPS BETWEEN THE DRILL SLEEVE AND THE HOLE CAUSED THE DRILL HOLE TO SHIFT AND THE DRILL BIT INTERFERED WITH THE NAIL. THE SURGEON DRILLED MANUALLY AT THE SURGEON¿S DISCRETION AND SUCCEEDED IN MAKING A HOLE. THE SCREW WAS INSERTED SUCCESSFULLY. WHEN THE SURGEON WAS INSERTING DISTAL LOCKING SCREWS, DRILLING WAS DONE SMOOTHLY FOR ONE OF THE LOCKING SCREWS, AND THE DRILL BIT WAS LEFT FOR FIXATION. HOWEVER, ANOTHER DRILL BIT ALSO INTERFERED WITH THE NAIL WHEN IT WAS USED TO DRILL A HOLE FOR A 2ND DISTAL LOCKING SCREW. THE SURGEON DRILLED MANUALLY FOR THE HOLE AND INSERTED THE DISTAL LOCKING SCREW SUCCESSFULLY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. NO FRAGMENTS WERE LEFT IN THE PATIENT, THE SURGEON CONFIRMED THIS VIA X-RAY. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 12.0MM/8.0MM PROTECTION SLEEVE 188MM. THIS IS REPORT 2 OF 6 FOR (B

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18687667 ↗
• MalfunctionJan 16, 2024Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SLEEVES ARE BENT FROM NORMAL WEAR AND TEAR. THERE WERE NO PATIENT OUTCOMES REPORTED. THIS REPORT IS FOR ONE (1) 12.0MM/8.0MM PROTECTION SLEEVE 188MM. THIS IS REPORT 4 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18519694 ↗
• MalfunctionSep 28, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM COLOMBIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, THE PROTECTION SLEEVE DID NOT FIT INTO THE 125 HOLE. THERE WAS NO PATIENT IMPACT, THE SURGEON DECIDED TO IMPLANT THE SCREWS IN THE HEAD. NO ADDITIONAL INFORMATION IS AVAILABLE TO REPORT. THIS REPORT IS FOR A 12.0MM/8.0MM PROTECTION SLEEVE 188MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17838094 ↗
• MalfunctionSep 21, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH AN UNKNOWN DELAY.

  Patient problems: Insufficient Information

  MAUDE report 17788335 ↗
• MalfunctionJul 27, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED THAT DURING SURGERY ON (B)(6), 2023, THE PROTECTION SLEEVE DID NOT PASS THROUGH THE ANTEROGRADE LOCKING HOLE IN THE INSERTION ARC. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 12.0MM/8.0MM PROTECTION SLEEVE 188MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17404390 ↗
• MalfunctionApr 18, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN ITALY AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE INSERTION HANDLE AND PROTECTION SLEEVE STAYED LOCKED TOGETHER. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 12.0MM/8.0MM PROTECTION SLEEVE 188MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16763520 ↗
• MalfunctionDec 27, 2022Contamination /Decontamination Problem; Device-Device Incompatibility; Contamination /Decontamination Problem; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE AIMING ARM WAS OUT OF CALIBRATION. WHEN THE DRILL BIT WAS PASSED THROUGH IT DID NOT COINCIDE WITH THE HOLE OF THE NAIL AND THE BIT GOT STUCK. THE TISSUE PROTECTION SLEEVE AND THE DRILL SLEEVE WERE DIRTY WITH DEBRIS INSIDE. FOR THIS REASON, THE DOCTOR CHANGED THE SURGICAL PLAN. THERE WAS A DELAY IN THE PROCEDURE AS A RESULT. THE PATIENT WAS AFFECTED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 12.0MM/8.0MM PROTECTION SLEEVE 188MM THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16053209 ↗
• MalfunctionAug 9, 2022Device-Device Incompatibility; No Apparent Adverse Event; Device-Device Incompatibility; No Apparent Adverse Event

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN PORTUGAL AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT - 03.010.041 B 14.0/3.2 MM PUNZÓN, DAMAGED CANULATED. REPLACE. 03.010.063 HYSTIC PROTECTION PLANE 12.0/8.0, LONGITUD 188 MM, AND A 03.010.065 BIT GUIDE 8.0/4.2, FOR PART NO. 03.010.063, VERY DIFFICULT TO REMOVE FROM EACH OTHER, CHECK THERE WAS NO SURGICAL DELAY. THERE WAS ALTERATION OF THE TECHNIQUE BY ANOTHER SURGICAL OPTION EXISTING IN THE SURGICAL INSTRUMENT, WITH NO IMPACT ON THE SURGERY. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1)PROTECT SLEEVE 12/8 L188. THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15190830 ↗
• MalfunctionAug 9, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN PORTUGAL AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT - 03.010.041 B 14.0/3.2 MM PUNZÓN, DAMAGED CANULATED. REPLACE. 03.010.063 HYSTIC PROTECTION PLANE 12.0/8.0, LONGITUD 188 MM, AND A - 03.010.065 BIT GUIDE 8.0/4.2, FOR PART NO. 03.010.063, VERY DIFFICULT TO REMOVE FROM EACH OTHER, CHECK. THERE WAS NO SURGICAL DELAY. THERE WAS ALTERATION OF THE TECHNIQUE BY ANOTHER SURGICAL OPTION EXISTING IN THE SURGICAL INSTRUMENT, WITH NO IMPACT ON THE SURGERY. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) PROTECT SLEEVE 12/8 L188. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15190819 ↗
• MalfunctionJun 10, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED ON (B)(6) 2022, THE 12MM PROTECTION SLEEVE, DRILL SLEEVE AND TROCAR GOT STUCK IN THE TARGETING ARM OF THE ADOLESCENT LATERAL ENTRY FEMORAL NAIL. SURGERY WAS COMPLETED WITH A SURGICAL DELAY OF 30 MINUTES. THERE WAS A PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) INSRT HANDLE F/ADOLESCENT LFN NAIL-EX THIS IS REPORT 3 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14653892 ↗