PLIF 273128001Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10705034186962), received between May 6, 2024 and Sep 9, 2026 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (11 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. How this data works · Data updated Oct 13, 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.

• MalfunctionSep 9, 2026Device-Device Incompatibility

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50698669 ↗
• MalfunctionMay 13, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT A CONDUIT TRIAL HANDLE AND SHAVER SIZE 7 STUCK TOGETHER. CLEANING STAFF WERE UNABLE TO DISASSEMBLE THEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25163649 ↗
• MalfunctionApr 8, 2026Break

  IT WAS REPORTED THAT A NEW HANDPIECE FROM LLIF IS BROKEN. THERE WAS NO SURGICAL DELAY AND NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24821465 ↗
• MalfunctionMar 30, 2026Break; Crack; Device-Device Incompatibility

  IT WAS REPORTED THAT THE HANDLE CRACKED AND BROKE WHEN LIGHT MALLETING WAS REQUIRED FOR EXTRACTION FROM THE DISC SPACE. ON REMOVING THE INSTRUMENT, HANDLE AND DISTRACTOR, THE 7MM DISTRACTOR WAS OBSERVED TO BE JAMMED IN THE HANDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24718593 ↗
• MalfunctionJan 27, 2026Break

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE. BEFORE THE SURGERY, WHEN THE DISTRIBUTOR OPENED THE HANDLES FOR SORTING, IT WAS CONFIRMED THAT ONE OF THE HANDLES HAD BROKEN. THE OTHER HANDLE WAS THERE, SO ITHER WAS NO AFFECT ON THE SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24189575 ↗
• MalfunctionDec 15, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT A 7MM SHAVER (PFT10700T) AND T-HANDLE (273128001) GOT STUCK AFTER SURGERY. INSTRUMENTS ARE NOT ABLE TO CONNECT TO EACH OTHER. THERE WAS NO PATIENT HARM AND NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23810416 ↗
• MalfunctionDec 8, 2025Device-Device Incompatibility; Device-Device Incompatibility

  ADDITIONAL INFORMATION RECEIVED: THE INSTRUMENTAL HAD 2 T-FISTS, AND NONE OF THE 2 HAD THE CORRECT FIT FOR THE SHAVERS THAT WERE IN THE INSTRUMENTAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23743606 ↗
• MalfunctionOct 16, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A MIS TLI, IT WAS NOTICED THAT THE HANDLES FOR THE SHAVERS AND SPREADERS WEREN´T COMPATIBLE ON THE INSTRUMENT SET CONDUIT TLIF. AS A RESULT, THE CONDUIT TLIF CAGE COULD NOT BE IMPLANTED IN THE PATIENT. THE PROCEDURE WAS NOT COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23316548 ↗
• MalfunctionJul 21, 2025Break; Break

  IT WAS REPORTED A TLIF (L4/5,L5/S) PERFORMED ON (B)(6) 2025. IN THE SURGERY, WITH THE MODULAR T-HANDLE AND PSG DISTRACTOR IN PLACE, THE SURGEON INSERTED IT INTO THE L5/S VERTEBRAE, AND HE TAPPED THE HANDLE OF THE MODULAR T-HANDLE WITH A HAMMER, THE HANDLE BROKE. A SPARE HANDLE WAS USED AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22557043 ↗
• MalfunctionMar 5, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT THE CONDITION OF THE INSTRUMENTS JEOPARDIZED THE SUCCESS OF THE SURGERY, THE INSTRUMENTS WERE CLEARLY WORN AND COULD NOT PROPERLY LATCH AND UNLATCH HANDLES.

  Patient problems: Insufficient Information

  MAUDE report 21528607 ↗
• MalfunctionNov 4, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE DISTRACTOR AND HANDLE ARE BLOCKED TOGETHER AND IMPOSSIBLE TO REMOVE THE HANDLE. IT WAS UNKNOWN IF SURGERY WAS DELAYED DUE TO THE REPORTED EVENT. IT WAS ALSO UNKNOWN IF THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20599664 ↗
• MalfunctionSep 19, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED DURING A PROCEDURE ON AN UNKNOWN DATE IN 2024, ONE DISTRACTOR AND 2 SHAVERS COULDN¿T BE TAKEN AWAY FROM THEIR HANDLE. NO IMPACT ON SURGERY, NO IMPACT ON PATIENT. NO SURGICAL DELAY. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20255226 ↗
• MalfunctionSep 17, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED DURING A PROCEDURE ON AN UNKNOWN DATE IN 2024, ONE DISTRACTOR AND 2 SHAVERS COULDN'T BE TAKEN AWAY FROM THEIR HANDLE. NO IMPACT ON SURGERY, NO IMPACT ON PATIENT. NO SURGICAL DELAY. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20241501 ↗
• MalfunctionSep 17, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED DURING A PROCEDURE ON AN UNKNOWN DATE IN 2024, ONE DISTRACTOR AND 2 SHAVERS COULDN¿T BE TAKEN AWAY FROM THEIR HANDLE. NO IMPACT ON SURGERY, NO IMPACT ON PATIENT. NO SURGICAL DELAY. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20241433 ↗
• MalfunctionMay 6, 2024Break; Break

  IT WAS REPORTED THAT THIS WAS A SPINAL FUSION (LUMBAR VERTEBRAE) FOR MOB ON (B)(6) 2024. IN THE SURGERY, WHEN LIGHTLY STRUCK WITH A HAMMER, THE HANDLE IN QUESTION SEPARATED INTO TWO PIECES AND WAS DAMAGED. THERE WAS NO DEBRIS AND NO IMPACT ON THE PATIENT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) PLIF SG INSTRUMENTS STANDARD T-HANDLE THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19251071 ↗