MAUDE Adverse Event Report: STRYKER SPINE-FRANCE XIA TITANIUM 4.5 EXTENDED CONNECTOR LARGE; SPINAL INTERLAMINAL FIXATION ORTHOSIS

Catalog Number	48135104
Health Effect - Clinical Code	No Information (3190)
Date of Event	05/31/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that; broken connector removed from patient.

• Brand Name: XIA TITANIUM 4.5 EXTENDED CONNECTOR LARGE
• Common Device Name: SPINAL INTERLAMINAL FIXATION ORTHOSIS
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 5753060
• Report Number: 0009617544-2016-00252
• Device Sequence Number: 490168
• Product Code: KWP
• UDI-Device Identifier: 04546540449597
• UDI-Public: (01)04546540449597
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121342
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/01/2016

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: 48135104
• Device Lot Number: 058884
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2016
• Initial Report FDA Received Date: 06/27/2016
• 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