MAUDE Adverse Event Report: STRYKER SPINE-FRANCE XIA 3 TITANIUM MULTIAXIAL CROSSLINK 43MM 54MM; PEDICLE SCREW SPINAL SYSTEM

Catalog Number	48236043
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Injury (2348); No Code Available (3191)
Date of Event	04/27/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; on (b)(6) 2014, (th10-s2ai) surgery was performed.After that, the breakage of the both side rod at under l4 was found.The mac was also broken at l5/s1 and the screw was also broken at left sai.So the revision surgery was performed on (b)(6) 2016, at l4/5 was done.The spinal deformity of the patient was terrible.
Additional Manufacturer Narrative
Method: device history review, complaint history review, risk assessment; result: manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.The product was not returned for inspection.Conclusion: the root cause of the event could not be determined with the given information.
Event or Problem Description
It was reported that; on (b)(6) 2014, (th10-s2ai) surgery was performed.After that, the breakage of the both side rod at under l4 was found.The mac was also broken at l5/s1 and the screw was also broken at left sai.So the revision surgery was performed on (b)(6) 2016, at l4/5 was done.The spinal deformity of the patient was terrible.

• Brand Name: XIA 3 TITANIUM MULTIAXIAL CROSSLINK 43MM 54MM
• Common Device Name: PEDICLE SCREW SPINAL SYSTEM
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 5680356
• Report Number: 0009617544-2016-00208
• Device Sequence Number: 10810460
• Product Code: MNH
• UDI-Device Identifier: 04546540560872
• UDI-Public: (01)04546540560872
• Combination Product (Y/N): N
• PMA/510(K) Number: K113666
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2017

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: 48236043
• Device Lot Number: 13E503
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/27/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/25/2016
• Supplement Report FDA Received Date: 01/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 79 YR