inforMED
InjuryOSH

XIA 3 TITANIUM ROD DIAM 6MM CP TI L 600MM

Received Nov 16, 2015 · Event occurred Oct 1, 2015

Report 0009617544-2015-00484 · MDR key 5225272

Device

Generic name

Pedicle Screw Spinal System

Catalog number

48232600

Lot number

UNKNOWN

Product problems

  • Break
  • Material Integrity Problem

Patient

Not reported

  • Injury
  • No Code Available

Narrative

Additional Manufacturer Narrative

METHOD: COMPLAINT HISTORY REVIEW; RISK ASSESSMENT; RESULTS: IT WAS REPORTED THAT THE DEVICE WAS IMPLANTED FOR OVER 24 MONTHS. THE IFU STATES: ¿STRESSES AND STRAINS ON THE IMPLANTS MAY CAUSE METAL FATIGUE OR FRACTURE OR DEFORMATION OF THE IMPLANTS, BEFORE THE BONE GRAFT HAS BECOME COMPLETELY CONSOLIDATED. WHILE THE EXPECTED LIFE OF SPINAL IMPLANT COMPONENTS IS DIFFICULT TO ESTIMATE, IT IS FINITE¿ CONCLUSION: THE MOST LIKELY CAUSE OF THE EVENT IS FATIGUE OF THE DEVICES DUE TO THE LENGTH OF IMPLANTATION.

Description of Event or Problem

IT WAS REPORTED THAT ON (B)(6) 2013, THE PATIENT UNDERWENT XIA3 SURGERY. ON (B)(6) 2015, THE SURGEON CONFIRMED THE X-RAY AND FOUND THAT THE ROD WAS BROKEN(L3-L4). THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2015.

Description of Event or Problem

IT WAS REPORTED THAT ON (B)(6) 2013, THE PATIENT UNDERWENT XIA3 SURGERY. ON (B)(6) 2015, THE SURGEON CONFIRMED THE X-RAY AND FOUND THAT THE ROD WAS BROKEN (L3-L4). THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2015.