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

Catalog Number	03756230
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Injury (2348); No Known Impact Or Consequence To Patient (2692)
Date of Event	02/14/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: cobalt chrome rod broken.Blockers loose at t10, t11, l4, l5, s1, iliac bolt and offset connector.Screw loose at left s1.Multiple levels of nonunion.Replaced rod and affected screws.
Additional Manufacturer Narrative
Risk assessment; no product was returned and lot number was not provided, therefore device inspection, device history review and complaint history review could not be performed.Without the device inspection and further information the root cause cannot be determined conclusively.
Event or Problem Description
It was reported that: cobalt chrome rod broken.Blockers loose at t10, t11, l4, l5, s1, iliac bolt and offset connector.Screw loose at left s1.Multiple levels of nonunion.Replaced rod and affected screws.

• 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: 6408131
• Report Number: 3005525032-2017-00029
• Device Sequence Number: 16359001
• Product Code: KWP
• UDI-Device Identifier: 04546540147257
• UDI-Public: (01)04546540147257
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2017

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: 02/14/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/15/2017
• Supplement Report FDA Received Date: 06/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 127