XRL 03.807.358Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10705034723310), received between Sep 12, 2019 and May 16, 2025 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Calibration Problem” (15 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 16, 2025Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT AT A JNJ FACILITY ON AN UNKNOWN DATE, SEVERAL INSTRUMENTS FAILED A TORQUE LIMITING TEST. THE DEVICES ARE OUT OF CALIBRATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22038856 ↗
• MalfunctionOct 25, 2022Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING EVALUATION AT SERVICE AND REPAIR, IT WAS FOUND OUT THAT XRL LARGE TORQUE LIMITING HANDLE HAD FAILED IN CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE XRL LARGE TORQUE LIMITING HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15666056 ↗
• MalfunctionOct 24, 2022Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING EVALUATION AT SERVICE AND REPAIR, THE REPAIR TECHNICIANS FOUND THAT THIS DEVICE FAILED CALIBRATION. ISSUE WAS FOUND DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE XRL LARGE TORQUE LIMITING HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4)..

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15659642 ↗
• MalfunctionJun 23, 2022Calibration Problem; Calibration Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE USA AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING EVALUATION AT SERVICE AND REPAIR IT WAS FOUND OUT THAT XRL LARGE TORQUE LIMITING HANDLE HAD FAILED IN CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE(1) DEVICE XRL LARGE TORQUE LIMITING HANDLE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14786468 ↗
• MalfunctionJun 6, 2022Calibration Problem; Calibration Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE USA AS FOLLOWS: FAILED CALIBRATION. THIS COMPLAINT INVOLVES ONE (1) DEVICE XRL LARGE TORQUE LIMITING HANDLE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14604960 ↗
• MalfunctionJan 27, 2022Calibration Problem; Calibration Problem

  IT WAS REPORTED THE TORQUE LIMITING HANDLE FAILED CALIBRATION. THIS REPORT IS FOR A TORQUE LIMITING HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13369126 ↗
• MalfunctionDec 17, 2021Calibration Problem; Calibration Problem

  IT WAS REPORTED ON (B)(6) 2021, DURING EVALUATION THE REPAIR TECHNICIAN FOUND THAT THE LARGE TORQUE LIMITING HANDLE PART FAILED THE TORQUE TEST. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) XRL LARGE TORQUE LIMITING HANDLE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13028100 ↗
• MalfunctionNov 24, 2021Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A TORQUE LIMITING HANDLE FAILED IN CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR A TOQUE LIMITING HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12868340 ↗
• MalfunctionOct 15, 2020Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT DURING TESTING AT SERVICE AND REPAIR IT WAS FOUND OUT THAT THE LARGE TORQUE LIMITING HANDLE HAD FAILED IN CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR 1 XRL LARGE TORQUE LIMITING HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10687456 ↗
• MalfunctionMay 20, 2020Calibration Problem; Calibration Problem

  IT WAS REPORTED ON (B)(6) 2020, DURING EVALUATION, THE REPAIR TECHNICIANS FOUND THAT AN EXPANDABLE RADIOLUCENT VERTEBRAL BODY REPLACEMENT SYSTEM (XRL) LARGE TORQUE LIMITING HANDLE FAILED CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE (1) XRL LARGE TORQUE LIMITING HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10074756 ↗
• MalfunctionJan 24, 2020Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING TESTING AT SERVICE AND REPAIR, THE XRL TORQUE LIMITING HANDLE FAILED IN CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9629107 ↗
• MalfunctionOct 10, 2019Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING EVALUATION AT SERVICE AND REPAIR, THE LARGE TORQUE LIMITING HANDLE HAS FAILED IN CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) XRL LARGE TORQUE LIMITING HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9175489 ↗
• MalfunctionOct 2, 2019Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON (B)(6) 2018, DURING TESTING AT SERVICE AND REPAIR, A LARGE TORQUE LIMITING HANDLE FAILED IN CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9147561 ↗
• MalfunctionSep 16, 2019Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON JULY 17, 2019, DURING TESTING AT SERVICE AND REPAIR, A TORQUE LIMITING HANDLE FAILED IN CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9069795 ↗
• MalfunctionSep 12, 2019Calibration Problem; Calibration Problem

  IT WAS REPORTED ON (B)(6) 2019, DURING EVALUATION AND TESTING AT SERVICE AND REPAIR, AN XRL LARGE TORQUE LIMITING HANDLE WAS FOUND TO HAVE FAILED IN CALIBRATION. THERE WAS NO PATIENT NOR PROCEDURE INVOLVEMENT. THIS COMPLAINT INVOLVES (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9009944 ↗