MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND XIA LP MONOAXIAL SCREW 6.5 X 50MM; SPINAL INTERLAMINAL FIXATION ORTHOSIS

Model Number	03820650
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Date of Event	04/15/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that; the patient felt a pain in the lumbar spine.Doctor found screws has broken.The doctor has removed the broken screws, and patient continue to follow-up treatment in rehabilitation department.
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 device is not available for evaluation.Conclusion: the definitive root cause of the event cannot be determined as device is not evaluation and additional information on patient and patient activity could not be retrieved.
Event or Problem Description
It was reported that; the patient felt a pain in the lumbar spine.Doctor found screws has broken.The doctor has removed the broken screws, and patient continue to follow-up treatment in rehabilitation department.

• Brand Name: XIA LP MONOAXIAL SCREW 6.5 X 50MM
• Common Device Name: SPINAL INTERLAMINAL FIXATION ORTHOSIS
• Manufacturer (Section D): STRYKER SPINE-SWITZERLAND; le crêt-du-locle 10 a; -; la chaux-de-fonds 2300 ; CH 2300
• MDR Report Key: 6616581
• Report Number: 3005525032-2017-00066
• Device Sequence Number: 19034720
• Product Code: KWP
• UDI-Device Identifier: 04546540148926
• UDI-Public: (01)04546540148926
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: K013823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2017

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: 03820650
• Device Catalogue Number: 03820650
• Device Lot Number: B43070
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/09/2017
• Supplement Date Received by Manufacturer: 05/09/2017
• Initial Report FDA Received Date: 06/06/2017
• Supplement Report FDA Received Date: 09/29/2017
• 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: Other
• Patient Age: 51 YR