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

Model Number	03821540
Medical Device Problem Codes	Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Codes	Pain (1994); No Information (3190)
Date of Event	06/30/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that; screws broke.
Additional Manufacturer Narrative
Lot #: b21590.Method: x-rays review, device history review, complaint history review, risk assessment; result: the customer reported event was confirmed based on provided x-rays.Manufacturing records were reviewed and no relevant issues were identified.The product is not available for inspection as it remains implanted.The device is implanted for 3 years.There is significant bone ossification indicating that the patient has fused.Conclusion: the product is not available for inspection hence a definitive root cause cannot be determined.
Event or Problem Description
It was reported that; screws broke.

• Brand Name: XIA LP POLYAXIAL SCREW 5.5 X 40MM
• Common Device Name: SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS
• Manufacturer (Section D): STRYKER SPINE-SWITZERLAND; le crêt-du-locle 10 a; -; la chaux-de-fonds 2300 ; CH 2300
• MDR Report Key: 6976221
• Report Number: 3005525032-2017-00098
• Device Sequence Number: 19121880
• Product Code: KWQ
• UDI-Device Identifier: 04546540149176
• UDI-Public: (01)04546540149176
• Combination Product (Y/N): N
• PMA/510(K) Number: K060361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2018

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: 03821540
• Device Catalogue Number: 03821540
• Device Lot Number: B21590
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/29/2017
• Supplement Date Received by Manufacturer: 09/29/2017
• Initial Report FDA Received Date: 10/25/2017
• Supplement Report FDA Received Date: 01/03/2018
• 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: 62 YR