MAUDE Adverse Event Report: STRYKER SPINE-FRANCE XIA TITANIUM 4.5 VITALIUM ROD 4.5 X 600 MM; PEDICLE SCREW SPINAL SYSTEM

Catalog Number	48132601
Medical Device Problem Codes	Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Codes	Injury (2348); No Code Available (3191)
Date of Event	12/01/2015
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that; rods were found to be broken and were revised.
Additional Manufacturer Narrative
Method: complaint history review; risk assessment; results: manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.It was confirmed that the device was implanted for over 2 years.The ifu states the following: "once implanted, the implants are subjected to stresses and strains.These repeated stresses on the implants should be taken into consideration by the surgeon at the time of the choice of the implant, during implantation as well as in the post-operative follow-up period.Conclusion: a definite root cause could not be determined as no device and limited information was received back.However, it is likely that the length of implantation contributed to the event.
Event or Problem Description
It was reported that; rods were found to be broken and were revised.

• Brand Name: XIA TITANIUM 4.5 VITALIUM ROD 4.5 X 600 MM
• Common Device Name: PEDICLE SCREW SPINAL SYSTEM
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 5492130
• Report Number: 0009617544-2016-00113
• Device Sequence Number: 338848
• Product Code: MNI
• UDI-Device Identifier: 04546540539663
• UDI-Public: (01)04546540539663
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K121342
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Catalogue Number: 48132601
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/17/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/10/2016
• Supplement Report FDA Received Date: 07/27/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 13 YR