NA 03.100.019Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982070685), received between Mar 7, 2017 and Nov 4, 2022 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• 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 STRAIGHT BALL SPIKE FOR LOW PROFILE PELVIC SYSTEM-LONG. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: Perforation of Vessels

  MAUDE report 15729117 ↗
• MalfunctionMay 21, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT, THE NON-ACCEPTANCE OF THE INSTRUMENT WITH CABLE IN CELERON MATERIAL BY THE UNIMED HOSPITAL MATERIALS CENTER, WE CONSULTED WITH NURSE (B)(6), RESPONSIBLE FOR THE TECHNICAL AREA OF THE HOSPITAL'S MATERIALS CENTER. IT IS A MATERIAL THAT HAS POROSITY DUE TO EXPOSURE TO THE TEMPERATURE OF THE STERILIZATION PROCESS. IT IS THE POROSITY OF THE CELERON THAT COMPROMISES THE CLEANING PROCESS. IT WAS UNDERSTOOD THEN THAT THE MATERIAL COMPROMISES THE STERILIZATION PROCESS, SINCE IT HAS POROSITY THAT DOES NOT GUARANTEE THE EFFECTIVENESS OF CLEANING. IF YOU ARE NOT IN ACCORDANCE WITH THE JUSTIFICATION PRESENTED, I SUGGEST THAT YOU PRESENT TO THE HOSPITAL TECHNICIANS RESPONSIBLE, A DOCUMENT WITH THE MANUFACTURER'S SPECIFICATIONS THAT MEET THE STANDARDS OF THE MANUALS OF GOOD CLEANING AND STERILIZATION PRACTICES. THIS REPORT IS FOR ONE (1) STRAIGHT BALL SPIKE FOR LOW PROFILE PELVIC SYSTEM-LONG. THIS IS REPORT 12 OF 15 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11866450 ↗
• MalfunctionApr 22, 2021Break; Use of Device Problem; Break; Use of Device Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 DURING AN UNKNOWN PROCEDURE, THE STRAIGHT BALL SPIKE BROKE. THE METAL TOP DISCONNECTED FROM THE HANDLE AND A PIN WAS MISSING. X-RAY WAS PERFORMED TO CONFIRM THAT THE PIN WAS NOT LEFT IN THE PATIENT. THERE WAS NO PATIENT CONSEQUENCE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH AN UNKNOWN AMOUNT OF SURGICAL DELAY. THIS REPORT IS FOR ONE (1) STRAIGHT BALL SPIKE FOR LOW PROFILE PELVIC SYSTEM-LONG. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11712383 ↗
• MalfunctionMar 7, 2017Break; Break

  (B)(6) REPORTED THE FOLLOWING: IT WAS REPORTED THAT FOLLOWING THREE (3) INSTRUMENTS WERE IDENTIFIED AS DAMAGED. A BALL SPIKE PUSHER TIP IS BROKEN AND TWO DEPTH GAUGES HAVE PRONGS WHICH ARE BROKEN. THIS WAS NOTICED IN THE STERILE PROCESSING DEPARTMENT. NO PROCEDURE OR PATIENT INVOLVEMENT WAS REPORTED. THIS REPORT IS FOR ONE (1) STRAIGHT BALL SPIKE FOR LOW PROFILE PELVIC SYSTEM-LONG. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6384144 ↗