MAUDE Adverse Event Report: STRYKER SPINE-FRANCE XIA TITANIUM 4.5 R T R CONNECTOR PARALLEL SMALL 4.5 - 4.5; PEDICLE SCREW SPINAL SYSTEM.

Catalog Number	48135005
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/05/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient underwent the surgery without fusion.On (b)(6) 2016, the patient underwent the surgery of the rod extension.When the surgeon tried loosened the set screw of the connector, the set screw deformed.Therefore the surgeon changed the extension part to another part.
Additional Manufacturer Narrative
Risk assessment.No lot # was provided, so a manufacturing record review, device history review, and complaint history review could not be performed.The possible root cause of this event is not determined as the product was not returned for evaluation and insufficient information was provided.
Event or Problem Description
It was reported that the patient underwent the surgery without fusion.On (b)(6) 2016, the patient underwent the surgery of the rod extension.When the surgeon tried loosened the set screw of the connector, the set screw deformed.Therefore the surgeon changed the extension part to another part.

• Brand Name: XIA TITANIUM 4.5 R T R CONNECTOR PARALLEL SMALL 4.5 - 4.5
• Common Device Name: PEDICLE SCREW SPINAL SYSTEM.
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 5983311
• Report Number: 0009617544-2016-00382
• Device Sequence Number: 1613165
• Product Code: MNH
• UDI-Device Identifier: 04546540649331
• UDI-Public: (01)04546540649331
• Combination Product (Y/N): N
• PMA/510(K) Number: K092605
• 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): 09/05/2016

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: 48135005
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/05/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/28/2016
• Supplement Report FDA Received Date: 12/01/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 8 YR