TRITON SPINE THERAPY TABLE
Received Apr 6, 2012
Report 9616086-2012-00021 · MDR key 2545968
Product problems
- Break
- Improper or Incorrect Procedure or Method
Patient
Not reported
- No Patient Involvement
Narrative
Description of Event or Problem
NO PTS WERE INVOLVED, THE SALES REP WAS PERFORMING AN IN SERVICE AT THE CUSTOMER'S OFFICE, HE PULLED DOWN THE HAND LEVER, THE WELD BROKE AND THE SMALLER CHEST/HEAD SECTION BROKE. INITIAL INFO PROVIDED TO DJO ON (B)(6) 2012, WAS INSUFFICIENT IN THAT IT DID NOT SUGGEST THAT DEVICE FAILED TO MEET SPECIFICATIONS OR MALFUNCTIONED. THE INITIAL INFO PROVIDED DID NOT SUGGEST THAT IF THE ALLEGED MALFUNCTION OR FAILURE TO MEET SPECIFICATIONS WERE TO RECUR IT WOULD CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY. PHOTOS OF THE BROKEN WELD WERE SENT TO DJO. THE PHOTOS REVEALED THAT THE WELD UNDER THE CHEST/HEAD SECTION (WHICH SUPPORTS THE PT'S UPPER BODY INCLUDING NECK AND BACK) IS BROKEN. ALTHOUGH A PT WAS NOT INVOLVED, THE PHOTOS REVEAL THAT A MALFUNCTION OF THE DEVICE OCCURRED, AND SUGGEST THAT WOULD THE MALFUNCTION WERE TO RECUR, IT CAN POSSIBLY CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY. GIVEN THE NEW INFO DJO HAS CLASSIFIED THE PRODUCT PROBLEM AS A REPORTABLE.