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

Catalog Number	48233600
Medical Device Problem Codes	Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/27/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; when the rod was bent with insitu bender, the rod was broken.After that, the rod was changed the new one and the operation was succeeded.
Additional Manufacturer Narrative
Lot# unknown.Method: risk assessment; results: visual, dimensional and complaint history review could not be performed as the device was not returned and lot# was not provided.Conclusion: the plausible root cause of the event was determined to be over bending of the rod resulting in fracture.
Event or Problem Description
It was reported that; when the rod was bent with insitu bender, the rod was broken.After that, the rod was changed the new one and the operation was succeeded.

• Brand Name: XIA 3 TITANIUM ROD DIAM 6MM TI ALLOY L 600MM
• Common Device Name: PEDICLE SCREW SPINAL SYSTEM
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6517299
• Report Number: 0009617544-2017-00163
• Device Sequence Number: 11357
• Product Code: MNH
• UDI-Device Identifier: 04546540560735
• UDI-Public: (01)04546540560735
• Combination Product (Y/N): N
• PMA/510(K) Number: K113666
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Catalogue Number: 48233600
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/27/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/24/2017
• Supplement Report FDA Received Date: 05/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 15 YR