NA 03.100.027Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10886982070760), received between Mar 27, 2019 and Feb 23, 2026 — classified as 6 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (5 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 23, 2026Break; Entrapment of Device

  IT WAS REPORTED THAT DURING THE SURGICAL PROCEDURE A TIP OF THE CANNULATED SCREWDRIVER CRACKED WHEN REMOVING A PREVIOUSLY IMPLANTED SCREW, PREVENTING PROPER ATTACHMENT AND FUNCTION. SUBSEQUENTLY, DURING THE DRILLING FOR THE PLACEMENT OF A NEW SCREW, THE 2.5 MM, 3-FLUTE DRILL BIT FRACTURED AND THE FRAGMENT REMAINED EMBEDDED IN THE BONE. FINALLY, DURING THE REDUCTION OF THE SACROILIAC JOINTS, THE REDUCTION PUNCH WAS USED IN CONJUNCTION WITH THE ROUND SUPPORT SHOE. UPON REMOVAL OF THE INSTRUMENTS, IT WAS OBSERVED THAT THE SUPPORT SHOE DETACHED AND REMAINED INSIDE THE PATIENT. MULTIPLE ATTEMPTS AT INTRAOPERATIVE EXTRACTION WERE MADE, WITHOUT SUCCESS AND WITHOUT ACHIEVING SAFE REMOVAL. THEREFORE, THE SURGICAL TEAM DECIDED TO LEAVE THE COMPONENT IN PLACE, PRIORITIZING PATIENT SAFETY.

  Patient problems: Foreign Body In Patient

  MAUDE report 24422811 ↗
• InjuryAug 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS REPORT IS RELATED TO (B)(4) WHICH REPORTED ON A ROUND SUPPORT SHOE, WHICH REMAINED INSIDE THE PATIENT'S BODY DURING THE FIRST SURGICAL PROCEDURE, MAKING IT IMPOSSIBLE TO REMOVE. ON (B)(6) 2025, THE PATIENT RETURNED FOR A SCHEDULED SECOND SURGICAL PROCEDURE TO PERFORM ADDITIONAL PELVIC FIXATION. DURING THIS PROCEDURE IT WAS POSSIBLE TO REMOVE THE ROUND SUPPORT SHOE WHICH WAS REMAINED IN THE PATIENT DURING FIRST PROCEDURE. THE SURGERY WAS COMPLETED SUCCESSFULLY, WITHOUT ANY PROBLEMS FOR THE PATIENT OR ALTERATIONS IN THE SURGICAL TIMES.

  Patient problems: Insufficient Information

  MAUDE report 22806530 ↗
• InjuryJul 1, 2025Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED DURING THE PROCEDURE A STRAIGHT PUNCH WITH ROUND SUPPORT SHOE WAS USED, AND THE SHOE REMAINED INSIDE THE PATIENT. AN EXPLORATORY LAPAROTOMY WAS PERFORMED TO LOOK FOR THIS PIECE, BUT IT WAS NOT FOUND. THE PATIENT EXPERIENCED FOUR (4) HOURS ADDITIONAL SURGICAL TIME AND ANESTHESIA AND BLOOD TRANSFUSION. AN ADDITIONAL CT SCAN AND A SECOND SURGERY IS PLANNED TO TRY TO REMOVE THE SUPPORT SHOE AGAIN.

  Patient problems: Foreign Body In Patient

  MAUDE report 22373057 ↗
• InjuryMay 12, 2025Entrapment of Device; Device-Device Incompatibility; Entrapment of Device; Device-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT UNDERWENT ORIF SURGERY FOR PELVIC FRACTURE WITH 2 ROUND DISKS. THE ROUND DISKS WERE USED WITH ATTACHING TO THE STRAIGHT BALL SPIKE, THEN ONE OF THE ROUND DISKS DROPPED OUT FROM THE STRAIGHT BALL SPIKE AND WAS LEFT IN THE PATIENT BODY DURING THE SURGERY. HOWEVER, THE SURGEON DID NOT NOTICE THAT. THE DROPOUT WAS CONFIRMED WITH THE X-RAY AFTER CLOSING THE SURGICAL INCISION, THEN THE ROUND DISK WAS REMOVED AT THE TIME. EXTRA ANESTHESIA WAS NEEDED FOR REMOVAL AND THERE WAS A HEMORRHAGE. ORIGINALLY, THE ROUND DISK AND THE STRAIGHT BALL SPIKE WERE DETACHABLE, SO THE SURGEON HAD AN UNDERSTANDING THAT THEY MAY COME OFF DURING THE SURGERY IN SOME CASES. HOWEVER, THE SURGEON DID NOT NOTICE THE DROPOUT EVEN THOUGH HE UNDERSTOOD IT. IT WAS UNKNOWN WITCH ROUND DISK OF 2 CAME OFF, BUT THE SURGEON INFORMED THAT BOTH EASILY CAME OFF. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH MORE THAN 30 MINUTES OF DELAY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22005358 ↗
• MalfunctionMar 13, 2024Entrapment of Device; Detachment of Device or Device Component; Entrapment of Device; Detachment of Device or Device Component

  DEVICE REPORT FROM CANADA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2024 DURING AN EMERGENCY ORTHOPEDIC SURGERY FOR PELVIC FRACTURES, THE ROUND DISK IN QUESTION WAS DISLODGED AND WAS UNABLE TO BE RETRIEVED FROM THE SURGICAL FIELD. THE PATIENT REQUIRED A SUBSEQUENT SURGERY TO RETRIEVE THE DISK THEN. THE DISK WAS RETRIEVED DURING THIS SECOND SURGERY WITH NO COMPLICATIONS. THE PIECE WAS DISCARDED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A ROUND DISK. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 18893738 ↗
• MalfunctionFeb 16, 2023Break; Device Slipped; Break; Device Slipped

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT UNDERWENT OPEN REDUCTION/INTERNAL FIXATION SURGERY WITH THE ROUND DISK IN QUESTION FOR A PELVIC FRACTURE ON (B)(6) 2023.THE ROUND DISC WAS USED IN COMBINATION WITH THE STRAIGHT BALL SPIKE. THE FIXATION SPRING OF THE ROUND DISC SEEMED TO BE DEFORMED OR LOOSENED, AND IT CAME OFF THE BODY. THEN, THE SURGEON TOLD THE STAFF TO PREPARE ANOTHER ROUND DISC. HOWEVER, THE STAFF PREPARED THE SAME DISC AND IT WAS USED. THE SPRING SEEMED TO HAVE BEEN FURTHER DEFORMED OR PARTIALLY BROKEN, AND IT CAME OFF THE BODY AGAIN. WHEN THE SURGEON CHECKED THE ROUND DISC, IT WAS CONFIRMED THAT THE SPRING WAS DEFORMED AND WAS BROKEN. THE BROKEN PART MIGHT HAVE REMAINED IN THE BODY. ALTHOUGH THE BROKEN PART WAS SEARCHED FOR USING THE IMAGE, IT COULD NOT BE FOUND. THE SURGEON GUESSED THAT THE BROKEN PART MIGHT HAVE BEEN REMOVED BY SUCTION. THE OPERATION WAS CONTINUED AND COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. THE PATIENT STATUS/OUTCOME WAS REPORTED TO BE STABLE. THIS REPORT INVOLVES ONE ROUND DISK. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16385849 ↗
• InjuryNov 4, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT ORIF FOR DISLOCATED FRACTURE OF THE SACROILIAC JOINT WITH THE PRODUCTS IN QUESTION. DURING THE RECONSTRUCTION PROCESS, WHEN THE TREATE BALL SPIKE AND SPIKE DISC WERE USED IN COMBINATION, DEEP BLOOD VESSELS WERE INJURED DUE TO THE SLIPPAGE OF THE PRODUCTS. THE PATIENT WAS IMMEDIATELY TREATED IN THE ANGIOGRAPHY ROOM, FOLLOWED BY PLATE FIXATION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A DELAY OF 40 MINUTES. THE SCHEDULED SURGERY TIME WAS 3 HOURS. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A ROUND DISK. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: Perforation of Vessels

  MAUDE report 15725145 ↗
• InjuryNov 4, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT ORIF FOR DISLOCATED FRACTURE OF THE SACROILIAC JOINT WITH THE PRODUCTS IN QUESTION. DURING THE RECONSTRUCTION PROCESS, WHEN THE TREATE BALL SPIKE AND SPIKE DISC WERE USED IN COMBINATION, DEEP BLOOD VESSELS WERE INJURED DUE TO THE SLIPPAGE OF THE PRODUCTS. THE PATIENT WAS IMMEDIATELY TREATED IN THE ANGIOGRAPHY ROOM, FOLLOWED BY PLATE FIXATION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A DELAY OF 40 MINUTES. THE SCHEDULED SURGERY TIME WAS 3 HOURS. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A ROUND DISK. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: Perforation of Vessels

  MAUDE report 15724656 ↗
• InjuryMay 6, 2021Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, DURING AN PELVIC FIXATION PROCEDURE THE PIECE CAME OFF, MIGRATING TO THE POSTERIOR PART OF THE PATIENT'S PELVIS. THIS MADE IT DIFFICULT TO REMOVE THE PIECE. ANOTHER SURGICAL PROCEDURE HAD TO BE PERFORMED TO REMOVE THE PIECE. NO FURTHER INFORMATION PROVIDED. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) ROUND DISK THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 11782937 ↗
• MalfunctionMar 27, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A DISC ROUND HOLE WAS FOUND TO BE DEFORMED. THERE WERE NO SURGICAL PROCEDURE AND PATIENT INVOLVEMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8455607 ↗