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

Catalog Number	48135104
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Date of Event	07/06/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that; the patient reported pain.During x-rays examination the surgeon noticed that the connector is broken and he decided to perform revision surgery to exchange broken elements of the system.
Additional Manufacturer Narrative
Visual analysis, device history review, complaint history review, risk assessment; manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.It was found that the connector was inspected and it was found to be returned in two pieces.The connector was fractured at the main shaft such that the end of the connector was completely fractured off.There was also a fracture going down the main shaft of the connector that didn't completely separate.The attempts to obtain additional information were unsuccessful.The definitive root cause of the event could not be determined from given information.
Event or Problem Description
It was reported that; the patient reported pain.During x-rays examination the surgeon noticed that the connector is broken and he decided to perform revision surgery to exchange broken elements of the system.

• 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: 5842770
• Report Number: 0009617544-2016-00320
• Device Sequence Number: 23053
• Product Code: KWP
• UDI-Device Identifier: 04546540449597
• UDI-Public: (01)04546540449597
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K121342
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2016

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: 142207
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 07/11/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/03/2016
• Supplement Report FDA Received Date: 11/03/2016
• 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