Tritanium X 580220101Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327366310), received between Sep 11, 2020 and Sep 11, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Mechanical Jam” (2 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Mar 11, 2021Terminated

   Stryker identified non-conforming instruments that are components of the Tritanium X TL sets. The firm found non-conformances with the TL Inserter, TL Draw Rod, Tube Set/Syringe Adapter Assembly, and Syringe Plunger that could lead to device failure during a procedure.

   Z-1437-2021 · Root cause: Device Design · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjurySep 11, 2020Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING A 3-LEVEL CASE (L2-L5), TWO (2) TRITANIUM X TL DRAW RODS WERE JAMMED/ DAMAGED IN THE INSERTER INTRA-OPERATIVELY. THE FIRST LEVEL (L4/5) IMPLANT WAS PLACED AS PLANNED, ACHIEVING THE DESIRED EXPANSION AND FINAL PLACEMENT. UPON IMPLANT INSERTION OF THE SECOND LEVEL (L3/4), THE INSERTER¿S DRAW ROD WOULD NOT DETACH FROM THE IMPLANT. THE SURGEON USED A SLAP HAMMER TO DISENGAGE THE IMPLANT BUT WAS UNABLE TO. THE IMPLANT WAS THEN REMOVED, UN-COLLAPSED (EXPANDED TO APPROXIMATELY 1MM) WITH THE INSERTER. A NEW INSERTER WAS THEN ASSEMBLED, AND A NEW IMPLANT WAS ATTACHED. BASED ON THE ANTEROPOSTERIOR X-RAYS, THE IMPLANT WAS PLACED SLIGHTLY PAST MIDLINE. THE SURGEON ATTEMPTED TO RE-ATTACH THE INSERTER TO ADJUST THE CAGE PLACEMENT CLOSER TO MIDLINE BUT WAS UNABLE TO RE-ATTACH. THE IMPLANT WAS LEFT AS IS WITH SATISFACTORY POSITIONING. THE INSERTER WAS TESTED ON THE BACK TABLE WHERE IT WAS DISCOVERED THAT THE DRAW ROD WAS DAMAGED AND NOT ABLE TO BE DISASSEMBLED FROM THE INSERTER. SUBSEQUENTLY, THE THIRD LEVEL (L2/3) WAS COMPLETED WITH AN ALTERNATE STATIC TITANIUM IMPLANT SYSTEM. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AND SURGERY WAS SUCCESSFULLY COMPLETED WITH

  Patient problems: Injury; No Clinical Signs, Symptoms or Conditions

  MAUDE report 10524781 ↗
• InjurySep 11, 2020Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING A 3-LEVEL CASE (L2-L5), TWO (2) TRITANIUM X TL DRAW RODS WERE JAMMED/ DAMAGED IN THE INSERTER INTRA-OPERATIVELY. THE FIRST LEVEL (L4/5) IMPLANT WAS PLACED AS PLANNED, ACHIEVING THE DESIRED EXPANSION AND FINAL PLACEMENT. UPON IMPLANT INSERTION OF THE SECOND LEVEL (L3/4), THE INSERTER¿S DRAW ROD WOULD NOT DETACH FROM THE IMPLANT. THE SURGEON USED A SLAP HAMMER TO DISENGAGE THE IMPLANT BUT WAS UNABLE TO. THE IMPLANT WAS THEN REMOVED, UN-COLLAPSED (EXPANDED TO APPROXIMATELY 1MM) WITH THE INSERTER. A NEW INSERTER WAS THEN ASSEMBLED, AND A NEW IMPLANT WAS ATTACHED. BASED ON THE ANTEROPOSTERIOR X-RAYS, THE IMPLANT WAS PLACED SLIGHTLY PAST MIDLINE. THE SURGEON ATTEMPTED TO RE-ATTACH THE INSERTER TO ADJUST THE CAGE PLACEMENT CLOSER TO MIDLINE BUT WAS UNABLE TO RE-ATTACH. THE IMPLANT WAS LEFT AS IS WITH SATISFACTORY POSITIONING. THE INSERTER WAS TESTED ON THE BACK TABLE WHERE IT WAS DISCOVERED THAT THE DRAW ROD WAS DAMAGED AND NOT ABLE TO BE DISASSEMBLED FROM THE INSERTER. SUBSEQUENTLY, THE THIRD LEVEL (L2/3) WAS COMPLETED WITH AN ALTERNATE STATIC TITANIUM IMPLANT SYSTEM. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AND SURGERY WAS SUCCESSFULLY COMPLETED WITH

  Patient problems: Injury; No Clinical Signs, Symptoms or Conditions

  MAUDE report 10524776 ↗