MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND XIA BLOCKER; SPINAL INTERLAMINAL FIXATION ORTHOSIS

Catalog Number	03756230
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Information (3190)
Date of Event	06/07/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; customer reported that the blocker broke in the screw and the event was observed during surgery.
Additional Manufacturer Narrative
Lot# c9c; visual inspection, device history review, complaint history review, risk assessment.No relevant manufacturing issues were identified during record review.Inspection of the device confirmed that the blocker sat flush with the top of the screw tulip and possessed sever deformation.The most likely cause of the customer reported event is over-torqueing during final tightening.
Event or Problem Description
It was reported that; customer reported that the blocker broke in the screw and the event was observed during surgery.

• Brand Name: XIA BLOCKER
• 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: 5803047
• Report Number: 3005525032-2016-00086
• Device Sequence Number: 10934495
• Product Code: KWP
• UDI-Device Identifier: 04546540147257
• UDI-Public: (01)04546540147257
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K060361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2016

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: C9C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/22/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/19/2016
• Supplement Report FDA Received Date: 12/20/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1