MAUDE Adverse Event Report: STRYKER SPINE-FRANCE XIA TITANIUM 4.5 EXTENDED CONNECTOR SMALL; PEDICLE SCREW SPINAL SYSTEM

Model Number	48135103
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Injury (2348); No Known Impact Or Consequence To Patient (2692)
Date of Event	05/16/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; a primary surgery for infant scoliosis was perfomred on (b)(6) 2014.During small growing rod extention surgery, a breakge of the extension connector was found and it was exchanged with othere new one.
Additional Manufacturer Narrative
Event or Problem Description
It was reported that; a primary surgery for infant scoliosis was performed on (b)(6) 2014.During small growing rod extension surgery, a breakage of the extension connector was found and it was exchanged with other new one.

• Brand Name: XIA TITANIUM 4.5 EXTENDED CONNECTOR SMALL
• Common Device Name: PEDICLE SCREW SPINAL SYSTEM
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6635480
• Report Number: 0009617544-2017-00238
• Device Sequence Number: 16296925
• Product Code: MNH
• UDI-Device Identifier: 04546540449580
• UDI-Public: (01)04546540449580
• Combination Product (Y/N): N
• 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): 08/24/2017

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 Model Number: 48135103
• Device Catalogue Number: 48135103
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/16/2017
• Supplement Date Received by Manufacturer: 05/16/2017
• Initial Report FDA Received Date: 06/12/2017
• Supplement Report FDA Received Date: 08/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 13 YR