MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND XIA LP POLYAXIAL SCREW 6.5 X 40MM; PEDICLE SCREW SPINAL SYSTEM

Catalog Number	03821640
Medical Device Problem Codes	Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Codes	Injury (2348); No Code Available (3191)
Date of Event	09/09/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that; lumbar revision of l4-s1.S1 screws were broken.Patient's last surgery was done in (b)(6) 2015.We had to replace the s1 screws.The 6.5x40mm were broken on the screw shaft.We had to drill them out and replace with 7.5x 50mm screws.
Additional Manufacturer Narrative
Method: device history review; complaint history review; risk assessment; results: it was confirmed that the patient did not fuse and had a strenuous profession.Manufacturing records for the related lot # did not reveal any relevant nonconformities.Conclusion: the most likely cause mode is a fatigue breakage due to lack of fusion.
Event or Problem Description
It was reported that; lumbar revision of l4-s1.S1 screws were broken.Patient's last surgery was done in (b)(6) 2015.We had to replace the s1 screws.The 6.5x40mm were broken on the screw shaft.We had to drill them out and replace with 7.5x 50mm screws.

• Brand Name: XIA LP POLYAXIAL SCREW 6.5 X 40MM
• Common Device Name: PEDICLE SCREW SPINAL SYSTEM
• Manufacturer (Section D): STRYKER SPINE-SWITZERLAND; le crêt-du-locle 10 a; -; la chaux-de-fonds 2300 ; CH 2300
• MDR Report Key: 5995382
• Report Number: 3005525032-2016-00123
• Device Sequence Number: 441346
• Product Code: NKB
• UDI-Device Identifier: 04546540149237
• UDI-Public: (01)04546540149237
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K060361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2016

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: 03821640
• Device Lot Number: B56696
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/09/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/03/2016
• Supplement Report FDA Received Date: 12/09/2016
• 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
• Patient Age: 51 YR