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

Catalog Number	48135103
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Injury (2348); No Code Available (3191)
Date of Event	06/29/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that; a primary surgery for infant scoliosis was performed on (b)(6) 2015.On (b)(6) 2016, third extension of the rods was performed.Then, a breakage of the extension connector was found and the revision of exchange of the connectors was performed on (b)(6) 2016.
Additional Manufacturer Narrative
No device was returned for evaluation, so visual and functional inspection could not be performed.No relevant manufacturing issues were identified for the reported lot number as all units met stryker specifications.No x rays or additional information about the construct was provided therefore this cannot be confirmed.Without the device or xrays to confirm the root cause cannot be conclusively determined.
Event or Problem Description
It was reported that; a primary surgery for infant scoliosis was performed on (b)(6) 2015.On (b)(6) 2016, third extension of the rods was performed.Then, a breakage of the extension connector was found and the revision of exchange of the connectors was performed on (b)(6) 2016.

• Brand Name: XIA TITANIUM 4.5 EXTENDED CONNECTOR SMALL
• Common Device Name: SPINAL INTERLAMINAL FIXATION ORTHOSIS
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 5821833
• Report Number: 0009617544-2016-00304
• Device Sequence Number: 13612968
• Product Code: KWP
• 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
• Device Implanted Year: 2015
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2016

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: 48135103
• Device Lot Number: 13A057
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/30/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/26/2016
• Supplement Report FDA Received Date: 11/18/2016
• 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