MAUDE Adverse Event Report: STRYKER SPINE-US XIA LP POLYAXIAL SCREW 5.5 X 40MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	03821540
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Injury (2348)
Date of Event	08/25/2015
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent revision surgery on (b)(6) 2015.Following surgery, the patient experienced pain.It was verified that a screw broke post operatively and another revision surgery would be necessary.Revision surgery has not been performed at this time.
Additional Manufacturer Narrative
The customer reported event was confirmed via correspondence.The device was not returned for evaluation.X-rays are not available for evaluation.Manufacturing history was reviewed and no issues were identified.The root cause of the reported event cannot be determined from the information provided.
Event or Problem Description
It was reported that a patient underwent revision surgery on (b)(6) 2015.Following surgery, the patient experienced pain.It was verified that a screw broke post operatively and another revision surgery would be necessary.Revision surgery has not been performed at this time.

• Brand Name: XIA LP POLYAXIAL SCREW 5.5 X 40MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; -; allendale NJ 07401
• MDR Report Key: 7379267
• Report Number: 3005525032-2018-00011
• Device Sequence Number: 1084248
• Product Code: NKB
• UDI-Device Identifier: 04546540149176
• UDI-Public: (01)04546540149176
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: BR
• PMA/510(K) Number: K060361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2018

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: B40396
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/29/2017
• Supplement Date Received by Manufacturer: 05/07/2018
• Initial Report FDA Received Date: 03/28/2018
• Supplement Report FDA Received Date: 06/04/2018
• 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: Required Intervention