MAUDE Adverse Event Report: STRYKER SPINE-FRANCE XIA LP MONOAXIAL SCREW 6.5 X 45MM; PEDICLE SCREW SPINAL SYSTEM

Model Number	03820645
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Date of Event	02/08/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that; the patient was found as l4-5ldr in 2015.The doctor inserted 4 6.5*45mm screws and 1 cage.One year after operation, the patient felt back pain, and x-ray showed the screw is broken.One screw'neck is broken.Doctor needs use another screw instead.
Additional Manufacturer Narrative
Method: risk assesment.Result: the customer reported event was confirmed via correspondence with the sales representative.The device was not returned and a valid lot number was not provided therefore manufacturing history could not be reviewed.The screw fracture was identified o1.5 year after the initial surgery.The patient was revised.Conclusion: due to the device not being returned, a definite root cause cannot be determined.
Event or Problem Description
It was reported that; the patient was found as l4-5ldr in 2015.The doctor inserted 4 6.5*45mm screws and 1 cage.One year after operation, the patient felt back pain, and x-ray showed the screw is broken.One screw'neck is broken.Doctor needs use another screw instead.

• Brand Name: XIA LP MONOAXIAL SCREW 6.5 X 45MM
• Common Device Name: PEDICLE SCREW SPINAL SYSTEM
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; -; cestas 33610 ; FR 33610
• MDR Report Key: 6419437
• Report Number: 3005525032-2017-00040
• Device Sequence Number: 16312228
• Product Code: NKB
• UDI-Device Identifier: 04546540148919
• UDI-Public: (01)04546540148919
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: K060361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2017

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 Model Number: 03820645
• Device Catalogue Number: 03820645
• Device Lot Number: UNKONWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/21/2017
• Supplement Date Received by Manufacturer: 02/21/2017
• Initial Report FDA Received Date: 03/20/2017
• Supplement Report FDA Received Date: 08/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1