Tritanium XRecalls & reported problems across all models

We found 3 models of Tritanium X by Stryker Corporation in the FDA's device registry (GUDID). Together they are named in 3 adverse event reports in the FDA's MAUDE database, received between Sep 11, 2020 and Feb 3, 2021 — classified as 2 injuries, 1 malfunction.

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

1 FDA recall record name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Tritanium X recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

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 · names 3 of these models · Recall details · FDA record ↗

Most reported Tritanium X problems

Tritanium X models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Tritanium X 580220101

  ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
  1 recall2 reports
• Tritanium X 580220100

  ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
  1 recall1 report
• Tritanium X 680220102

  Intervertebral fusion device with bone graft, lumbar
  1 recall0 reports

Recent Tritanium X adverse event reports

The 3 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionFeb 3, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING INTRA-OPERATIVE CAGE EXPANSION A TRITANIUM TL INSERTER WOULD NOT HOLD PRESSURE TO EXPAND THE IMPLANT AND BEGAN TO LEAK DURING USE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A 10 MINUTE SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11275986 ↗
• 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 ↗

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