T.L.I.F. 202718200Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 10705034184586), received between Oct 19, 2018 and Oct 22, 2025 — classified as 22 malfunctions.

The most frequently reported specific device problem is “Break” (18 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 18, 2026.

Most reported problems

Recent adverse event reports

The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 22, 2025Break; Break

  IT WAS REPORTED THAT THE METAL SPLIT IN RING THAT IS PLACED ON SCREW TO LOCK IT TO SCREW HEAD DURING DISTRACTION IS BROKEN. NO CONSEQUENCE FOR PATIENT. SURGERY PERFORMED AS PLANNED. ANOTHER INSTRUMENT WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23359290 ↗
• MalfunctionJul 1, 2025Break; Break

  IT WAS REPORTED THAT THE SPREADER BROKE WHEN SPREADING THE INTERVERTEBRAL DISC SPACE DURING A SPINE PROCEDURE. AFTER THE INNIES WERE PLACED AND THE PARALLEL DISTRACTION WAS PERFORMED, THE BAR WAS RIPPED OUT OF ITS HOLDER. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22373425 ↗
• MalfunctionJun 26, 2025Break; Break

  IT WAS REPORTED THAT THE DEPUY SPREADER BROKE WHEN SPREADING THE INTERVERTEBRAL DISC SPACE DURING A SPINAL FUSION SURGERY. AFTER THE INNIES WERE PLACED AND THE PARALLEL DISTRACTION WAS PERFORMED, THE BAR WAS RIPPED OUT OF ITS HOLDER. THE SPREADER HAS A WEAK POINT AT THE FRONT OF THE BAR BECAUSE IT IS NO LONGER CAST IN ONE PIECE BUT CONNECTED WITH DOTTED SOLDER JOINTS. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY AND NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22335551 ↗
• MalfunctionApr 22, 2025Break; Contamination /Decontamination Problem; Break; Contamination /Decontamination Problem

  IT WAS REPORTED THE ARM OF THE TLIF DISTRACTOR BROKE INTRA-OPERATIVELY DURING A LUMBAR FUSION SPINE PROCEDURE ON (B)(6) 2025. FRAGMENTS WERE GENERATED AND REMOVED EASILY WITHOUT ANY ADDITIONAL INTERVENTION. ANOTHER SET WAS OPENED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY OR CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21885148 ↗
• MalfunctionOct 9, 2024Break; Appropriate Device Problem Term/Code Not Available; Break; Appropriate Device Problem Term/Code Not Available

  ADDITIONAL INFORMATION RECEIVED STATES THAT AFTER RECEIVING THE PHYSICAL DEVICE, IT WAS CONFIRMED THE DEVICE HAD BROKEN AND BEEN WELDED BACK TOGETHER.

  Patient problems: Insufficient Information

  MAUDE report 20410208 ↗
• MalfunctionOct 3, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2024, THE DEVICE BROKE WHEN SPREADING THE INTERVERTEBRAL DISC SPACE. EITHER THE "ROD" CAME OFF THE "HOLDER" THAT WAS ATTACHED TO THE SCREWS WITH AN INNIE OR THE HOLDER BURST DURING DISTRACTION. SINCE THIS INSTRUMENT IS SUFFICIENTLY AVAILABLE IN THE OPERATING ROOM AT THE HOSPITAL, IT WAS ABLE TO BE REPLACED QUICKLY. THERE WERE NO NEGATIVE EFFECTS ON THE PATIENTS IN THESE CASES. THE FRAGMENTS WERE EASILY REMOVED.

  Patient problems: Insufficient Information

  MAUDE report 20361941 ↗
• MalfunctionAug 14, 2024Break; Break

  IT WAS REPORTED THAT PATIENTS UNDERWENT SPINAL FUSION PROCEDURES ON (B)(6) 2024. DURING THE PROCEDURES, SIX DISTRACTORS BROKE WHEN SPREADING THE INTERVERTEBRAL DISC SPACE. EITHER THE "ROD" CAME OFF THE "HOLDER" THAT WAS ATTACHED TO THE SCREWS WITH AN INNIE, OR THE HOLDER BURST DURING DISTRACTION. SINCE THIS INSTRUMENT IS SUFFICIENTLY AVAILABLE IN THE OPERATING ROOM AT THE HOSPITAL, IT WAS ABLE TO BE REPLACED QUICKLY. THERE WERE NO NEGATIVE EFFECTS ON THE PATIENTS IN THESE CASES. PROCEDURES WERE COMPLETED SUCCESSFULLY WITH NO DELAY. THIS REPORT IS FOR AN ARTICULATING DISTRACTOR. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19984755 ↗
• MalfunctionAug 14, 2024Break; Break

  IT WAS REPORTED THAT PATIENTS UNDERWENT SPINAL FUSION PROCEDURES ON (B)(6) 2024. DURING THE PROCEDURES, SIX DISTRACTORS BROKE WHEN SPREADING THE INTERVERTEBRAL DISC SPACE. EITHER THE "ROD" CAME OFF THE "HOLDER" THAT WAS ATTACHED TO THE SCREWS WITH AN INNIE, OR THE HOLDER BURST DURING DISTRACTION. SINCE THIS INSTRUMENT IS SUFFICIENTLY AVAILABLE IN THE OPERATING ROOM AT THE HOSPITAL, IT WAS ABLE TO BE REPLACED QUICKLY. THERE WERE NO NEGATIVE EFFECTS ON THE PATIENTS IN THESE CASES. PROCEDURES WERE COMPLETED SUCCESSFULLY WITH NO DELAY. THIS REPORT IS FOR AN ARTICULATING DISTRACTOR. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19984575 ↗
• MalfunctionAug 14, 2024Break; Break

  IT WAS REPORTED THAT PATIENTS UNDERWENT SPINAL FUSION PROCEDURES ON (B)(6) 2024. DURING THE PROCEDURES, SIX DISTRACTORS BROKE WHEN SPREADING THE INTERVERTEBRAL DISC SPACE. EITHER THE "ROD" CAME OFF THE "HOLDER" THAT WAS ATTACHED TO THE SCREWS WITH AN INNIE, OR THE HOLDER BURST DURING DISTRACTION. SINCE THIS INSTRUMENT IS SUFFICIENTLY AVAILABLE IN THE OPERATING ROOM AT THE HOSPITAL, IT WAS ABLE TO BE REPLACED QUICKLY. THERE WERE NO NEGATIVE EFFECTS ON THE PATIENTS IN THESE CASES. PROCEDURES WERE COMPLETED SUCCESSFULLY WITH NO DELAY. THIS REPORT IS FOR AN ARTICULATING DISTRACTOR. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19984462 ↗
• MalfunctionAug 14, 2024Break; Break

  IT WAS REPORTED THAT PATIENTS UNDERWENT SPINAL FUSION PROCEDURES ON (B)(6) 2024. DURING THE PROCEDURES, SIX DISTRACTORS BROKE WHEN SPREADING THE INTERVERTEBRAL DISC SPACE. EITHER THE "ROD" CAME OFF THE "HOLDER" THAT WAS ATTACHED TO THE SCREWS WITH AN INNIE, OR THE HOLDER BURST DURING DISTRACTION. SINCE THIS INSTRUMENT IS SUFFICIENTLY AVAILABLE IN THE OPERATING ROOM AT THE HOSPITAL, IT WAS ABLE TO BE REPLACED QUICKLY. THERE WERE NO NEGATIVE EFFECTS ON THE PATIENTS IN THESE CASES. PROCEDURES WERE COMPLETED SUCCESSFULLY WITH NO DELAY. THIS REPORT IS FOR AN ARTICULATING DISTRACTOR. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19983740 ↗
• MalfunctionAug 14, 2024Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT PATIENTS UNDERWENT SPINAL FUSION PROCEDURES ON (B)(6) 2024. DURING THE PROCEDURES, SIX DISTRACTORS BROKE WHEN SPREADING THE INTERVERTEBRAL DISC SPACE. EITHER THE "ROD" CAME OFF THE "HOLDER" THAT WAS ATTACHED TO THE SCREWS WITH AN INNIE, OR THE HOLDER BURST DURING DISTRACTION. SINCE THIS INSTRUMENT IS SUFFICIENTLY AVAILABLE IN THE OPERATING ROOM AT THE HOSPITAL, IT WAS ABLE TO BE REPLACED QUICKLY. THERE WERE NO NEGATIVE EFFECTS ON THE PATIENTS IN THESE CASES. PROCEDURES WERE COMPLETED SUCCESSFULLY WITH NO DELAY. THIS REPORT IS FOR AN ARTICULATING DISTRACTOR. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19983627 ↗
• MalfunctionAug 13, 2024Break; Break

  IT WAS REPORTED THAT PATIENTS UNDERWENT SPINAL FUSION PROCEDURES ON (B)(6), 2024. DURING THE PROCEDURES, SIX DISTRACTORS BROKE WHEN SPREADING THE INTERVERTEBRAL DISC SPACE. EITHER THE "ROD" CAME OFF THE "HOLDER" THAT WAS ATTACHED TO THE SCREWS WITH AN INNIE, OR THE HOLDER BURST DURING DISTRACTION. SINCE THIS INSTRUMENT IS SUFFICIENTLY AVAILABLE IN THE OPERATING ROOM AT THE HOSPITAL, IT WAS ABLE TO BE REPLACED QUICKLY. THERE WERE NO NEGATIVE EFFECTS ON THE PATIENTS IN THESE CASES. PROCEDURES WERE COMPLETED SUCCESSFULLY WITH NO DELAY. THIS REPORT IS FOR AN ARTICULATING DISTRACTOR. THIS IS REPORT 5 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19973158 ↗
• MalfunctionAug 13, 2024Break; Break

  IT WAS REPORTED THAT PATIENTS UNDERWENT SPINAL FUSION PROCEDURES ON (B)(6) 2024. DURING THE PROCEDURES, SIX DISTRACTORS BROKE WHEN SPREADING THE INTERVERTEBRAL DISC SPACE. EITHER THE "ROD" CAME OFF THE "HOLDER" THAT WAS ATTACHED TO THE SCREWS WITH AN INNIE, OR THE HOLDER BURST DURING DISTRACTION. SINCE THIS INSTRUMENT IS SUFFICIENTLY AVAILABLE IN THE OPERATING ROOM AT THE HOSPITAL, IT WAS ABLE TO BE REPLACED QUICKLY. THERE WERE NO NEGATIVE EFFECTS ON THE PATIENTS IN THESE CASES. PROCEDURES WERE COMPLETED SUCCESSFULLY WITH NO DELAY. THIS REPORT IS FOR AN ARTICULATING DISTRACTOR. THIS IS REPORT 6 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19973145 ↗
• MalfunctionAug 13, 2024Break; Break

  IT WAS REPORTED THAT PATIENTS UNDERWENT SPINAL FUSION PROCEDURES ON (B)(6) 2024. DURING THE PROCEDURES, SIX DISTRACTORS BROKE WHEN SPREADING THE INTERVERTEBRAL DISC SPACE. EITHER THE "ROD" CAME OFF THE "HOLDER" THAT WAS ATTACHED TO THE SCREWS WITH AN INNIE, OR THE HOLDER BURST DURING DISTRACTION. SINCE THIS INSTRUMENT IS SUFFICIENTLY AVAILABLE IN THE OPERATING ROOM AT THE HOSPITAL, IT WAS ABLE TO BE REPLACED QUICKLY. THERE WERE NO NEGATIVE EFFECTS ON THE PATIENTS IN THESE CASES. PROCEDURES WERE COMPLETED SUCCESSFULLY WITH NO DELAY. THIS REPORT IS FOR AN ARTICULATING DISTRACTOR. THIS IS REPORT 3 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19973129 ↗
• MalfunctionAug 13, 2024Break; Break

  IT WAS REPORTED THAT PATIENTS UNDERWENT SPINAL FUSION PROCEDURES ON (B)(6) 2024. DURING THE PROCEDURES, SIX DISTRACTORS BROKE WHEN SPREADING THE INTERVERTEBRAL DISC SPACE. EITHER THE "ROD" CAME OFF THE "HOLDER" THAT WAS ATTACHED TO THE SCREWS WITH AN INNIE, OR THE HOLDER BURST DURING DISTRACTION. SINCE THIS INSTRUMENT IS SUFFICIENTLY AVAILABLE IN THE OPERATING ROOM AT THE HOSPITAL, IT WAS ABLE TO BE REPLACED QUICKLY. THERE WERE NO NEGATIVE EFFECTS ON THE PATIENTS IN THESE CASES. PROCEDURES WERE COMPLETED SUCCESSFULLY WITH NO DELAY. THIS REPORT IS FOR AN ARTICULATING DISTRACTOR. THIS IS REPORT 4 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19973127 ↗
• MalfunctionAug 13, 2024Break; Break

  IT WAS REPORTED THAT PATIENTS UNDERWENT SPINAL FUSION PROCEDURES ON (B)(6), 2024. DURING THE PROCEDURES, SIX DISTRACTORS BROKE WHEN SPREADING THE INTERVERTEBRAL DISC SPACE. EITHER THE "ROD" CAME OFF THE "HOLDER" THAT WAS ATTACHED TO THE SCREWS WITH AN INNIE, OR THE HOLDER BURST DURING DISTRACTION. SINCE THIS INSTRUMENT IS SUFFICIENTLY AVAILABLE IN THE OPERATING ROOM AT THE HOSPITAL, IT WAS ABLE TO BE REPLACED QUICKLY. THERE WERE NO NEGATIVE EFFECTS ON THE PATIENTS IN THESE CASES. PROCEDURES WERE COMPLETED SUCCESSFULLY WITH NO DELAY. THIS REPORT IS FOR AN ARTICULATING DISTRACTOR. THIS IS REPORT 2 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19973069 ↗
• MalfunctionAug 13, 2024Break; Break

  IT WAS REPORTED THAT PATIENTS UNDERWENT SPINAL FUSION PROCEDURES ON (B)(6) 2024. DURING THE PROCEDURES, SIX DISTRACTORS BROKE WHEN SPREADING THE INTERVERTEBRAL DISC SPACE. EITHER THE "ROD" CAME OFF THE "HOLDER" THAT WAS ATTACHED TO THE SCREWS WITH AN INNIE, OR THE HOLDER BURST DURING DISTRACTION. SINCE THIS INSTRUMENT IS SUFFICIENTLY AVAILABLE IN THE OPERATING ROOM AT THE HOSPITAL, IT WAS ABLE TO BE REPLACED QUICKLY. THERE WERE NO NEGATIVE EFFECTS ON THE PATIENTS IN THESE CASES. PROCEDURES WERE COMPLETED SUCCESSFULLY WITH NO DELAY. THIS REPORT IS FOR AN ARTICULATING DISTRACTOR. THIS IS REPORT 1 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19973054 ↗
• MalfunctionNov 29, 2023Mechanical Jam; Mechanical Jam

  DEVICE REPORT FROM GERMANY REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT PREOPERATIVELY ON NOVEMBER 3, 2023, THE DISTRACTOR COULD NO LONGER BE MOVED. THERE WAS NO PATIENT HARM. THIS REPORT IS FOR AN ARTICULATING DISTRACTOR. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18229286 ↗
• MalfunctionAug 22, 2023Mechanical Jam; Mechanical Jam

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED THAT THE TAB BREAKER END WAS BROKEN AND THE TLIF SLIDER WAS JAMMED ON AUGUST 8, 2023. THE DAMAGE WAS IDENTIFIED DURING LOAN KIT INSPECTION. NO FURTHER DETAILS ARE AVAILABLE. THIS REPORT INVOLVES ONE T.L.I.F. SG INSTRUMENTS DISTRACTOR. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17595468 ↗
• MalfunctionJul 7, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN NETHERLANDS AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE DEVICE BROKE DOWN ¿ THE GEAR/WHEEL STOPPED WORKING. ANOTHER WAS AVAILABLE ON THE SET. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE T.L.I.F. SG INSTRUMENTS DISTRACTOR. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17277201 ↗
• MalfunctionJul 6, 2023Mechanical Problem; Mechanical Jam; Mechanical Problem; Mechanical Jam

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE MEDICAL DEVICE REPROCESSING DEPARTMENT IDENTIFIED THAT THE T LIFT DISTRACTOR WAS JAMMED AND DID NOT RATCHET ANYMORE. THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT INVOLVES ONE T.L.I.F. SG INSTRUMENTS DISTRACTOR. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17265563 ↗
• MalfunctionOct 19, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE SPREADER CAME APART IN STERILIZATION, PIECES MISSING NEEDING FULL REPLACEMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7986532 ↗