MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND XIA LP MONOAXIAL SCREW 5.5 X 40MM; SPINAL INTERLAMINAL FIXATION ORTHOSIS

Catalog Number	03820540
Medical Device Problem Codes	Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Codes	Injury (2348); Device Embedded In Tissue or Plaque (3165)
Date of Event	05/23/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that; the patient had thoracic surgery in (b)(6) 2012.The doctor used a screw.The patient had symptoms of lumbar acid in (b)(6) 2016 and found screw damaged in x-ray.The damaged product hasn't been taken out now.
Additional Manufacturer Narrative
Results: manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.The device was not received back for inspection.However, it was confirmed that the device had been implanted for over 3 years and the patient had fused, meaning the construct had served its purpose in supporting the spine during fusion.Conclusion: the most likely cause of the customer reported event is fatigue fracture due to prolonged implantation after fusion had occurred.
Event or Problem Description
It was reported that; the patient had thoracic surgery in (b)(6) 2012.The doctor used a screw.The patient had symptoms of lumbar acid in (b)(6) 2016 and found screw damaged in x-ray.The damaged product hasn't been taken out now.

• Brand Name: XIA LP MONOAXIAL SCREW 5.5 X 40MM
• 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: 5762242
• Report Number: 3005525032-2016-00072
• Device Sequence Number: 4999
• Product Code: KWP
• UDI-Device Identifier: 04546540148841
• UDI-Public: (01)04546540148841
• 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: 2012
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2016

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: 03820540
• Device Lot Number: B20976
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/07/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/30/2016
• Supplement Report FDA Received Date: 10/28/2016
• 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