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

Catalog Number	48135103
Medical Device Problem Codes	Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Date of Event	01/21/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the two extended connectors were found broken during revision operation and replaced new.The hospital can only return one of the products.
Additional Manufacturer Narrative
Method: device history review; complaint history review; risk assessment; results: this device was used in a "growing rod construct" in which the patient is fixed at two upper thoracic levels and at 2 lumbar levels, with no additional fixation in between.This is done in an attempt to fix a thoracic scoliosis curve.This existing curve and the placement of the devices allows for a large bending moment to exist within the non-fixed region, and can eventually cause the fatigue breakage of connector.Per the correspondence, the device was implanted for over 2 years.It is likely that the length of implantation along with the patient's activity level created loads and stresses on the device, which contributed to its eventual failure.The devices were discarded by the hospital and are unavailable for investigation.Conclusion: the cause of the reported event cannot be determined conclusively due to the absence of a sample to evaluate.
Event or Problem Description
It was reported that the two extended connectors were found broken during revision operation and replaced new.The hospital can only return one of the products.

• 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: 5458133
• Report Number: 0009617544-2016-00079
• Device Sequence Number: 10824610
• Product Code: KWP
• UDI-Device Identifier: 04546540449580
• UDI-Public: 04546540449580
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: K052761
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2016

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: 114954
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/04/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/24/2016
• Supplement Report FDA Received Date: 07/26/2016
• 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
• Patient Age: 8 YR
• Patient Weight: 35