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

Catalog Number	03756230
Medical Device Problem Codes	Mechanical Problem (1384); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Date of Event	04/21/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that; patient experienced low back pain.Surgeon suspected loose pedicle screw based off of slight radiolucency visible around lt l3 screw.
Additional Manufacturer Narrative
Risk assessment; no lot # was provided, so a manufacturing record review could not be performed.The probable root cause cannot be determined conclusively due to no device returned and insufficient information received.
Event or Problem Description
It was reported that; patient experienced low back pain.Surgeon suspected loose pedicle screw based off of slight radiolucency visible around lt l3 screw.

• 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: 5665000
• Report Number: 0009617544-2016-00194
• Device Sequence Number: 16216633
• Product Code: KWP
• UDI-Device Identifier: 04546540147257
• UDI-Public: (01)04546540147257
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: K060361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2016

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: 03756230
• Device Lot Number: UNKNOWN
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/21/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/18/2016
• Supplement Report FDA Received Date: 10/26/2016
• 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: 50 YR
• Patient Weight: 145