MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND XIA BLOCKER; PEDICLE SCREW SPINAL SYSTEM.

Catalog Number	03756230
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/06/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the doctor found the screw slip during the lumbar spine surgery and completed the surgery changing to another one.
Additional Manufacturer Narrative
Method: visual inspection; device history review; complaint history review; risk assessment; results: it was reported that the when the doctor tried to screw, the device slipped.No relevant manufacturing issues found.Poor alignment between blocker and hex driver may prevent blocker is to properly engage and may fall into wound.Conclusion: the possible root cause of this event is likely the poor alignment between the blocker and the hex driver and excessive force applied to the blocker.
Event or Problem Description
It was reported that the doctor found the screw slip during the lumbar spine surgery and completed the surgery changing to another one.

• Brand Name: XIA BLOCKER
• 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: 5613437
• Report Number: 3005525032-2016-00048
• Device Sequence Number: 181533
• Product Code: NKB
• UDI-Device Identifier: 04546540147257
• UDI-Public: (01)04546540147257
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: K982494
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Catalogue Number: 03756230
• Device Lot Number: DTR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/06/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/27/2016
• Supplement Report FDA Received Date: 07/06/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR