MAUDE Adverse Event Report: STRYKER SPINE-FRANCE XIA 3 TITANIUM ROD DIAM 6MM CP TI L 600MM; PEDICLE SCREW SPINAL SYSTEM

Catalog Number 48232600

Device Problems Break (1069); Material Integrity Problem (2978)

Patient Problems Injury (2348); No Code Available (3191)

Event Date 10/01/2015

Event Type  Injury  

Event Description

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.

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.

Event Description

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.

• Brand Name: XIA 3 TITANIUM ROD DIAM 6MM CP TI L 600MM
• Type of Device: PEDICLE SCREW SPINAL SYSTEM
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer (Section G): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer Contact: christa marrow ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 5225272
• MDR Text Key: 31313676
• Report Number: 0009617544-2015-00484
• Device Sequence Number: 1
• Product Code: OSH
• Combination Product (y/n): N
• PMA/PMN Number: K113666
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 48232600
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/20/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention