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

Catalog Number	03756230
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/11/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the surgery blocker was broken during primary locking.Clarification requested is in regards with the torque wrench and overtighten.
Additional Manufacturer Narrative
Risk assessment; no lot # was provided, so a manufacturing record review could not be performed.The root cause cannot be determined conclusively, as the device was not returned and insufficient information was received.
Event or Problem Description
It was reported that during the surgery blocker was broken during primary locking.Clarification requested is in regards with the torque wrench and overtighten.

• 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: 6099794
• Report Number: 3005525032-2016-00143
• Device Sequence Number: 748066
• Product Code: KWP
• UDI-Device Identifier: 04546540147257
• UDI-Public: (01)04546540147257
• Combination Product (Y/N): N
• Initial Reporter Country: LT
• 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): 01/17/2017

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/21/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/14/2016
• Supplement Report FDA Received Date: 01/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1