MAUDE Adverse Event Report: STRYKER SPINE-FRANCE TRIO LX SMALL CONNECTOR; SPINAL INTERLAMINAL FIXATION ORTHOSIS

Catalog Number	48902015
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/26/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; the patient underwent removing surgery on (b)(6)2016.The surgeon removed the screw and the offset connecter.After surgery, the connecter ring was remaining patient body when the surgeon checked the image.Therefore the surgeon is monitoring for the patient.(update (b)(6) 2016: the reason for the revision surgery was removal of the implants because the patient fused.
Additional Manufacturer Narrative
Risk assessment; the lot number is unknown and therefore no review of manufacturing information could be performed.A probable root cause could not be determined due to the unavailability of the device, lot code and images.
Event or Problem Description
It was reported that; the patient underwent removing surgery on (b)(6)2016.The surgeon removed the screw and the offset connecter.After surgery, the connecter ring was remaining patient body when the surgeon checked the image.Therefore the surgeon is monitoring for the patient.(update (b)(6) 2016): the reason for the revision surgery was removal of the implants because the patient fused.

• Brand Name: TRIO LX SMALL CONNECTOR
• Common Device Name: SPINAL INTERLAMINAL FIXATION ORTHOSIS
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6072224
• Report Number: 0009617544-2016-00440
• Device Sequence Number: 19255988
• Product Code: KWP
• UDI-Device Identifier: 04546540494160
• UDI-Public: (01)04546540494160
• Combination Product (Y/N): N
• PMA/510(K) Number: K070368
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2017

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 Catalogue Number: 48902015
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/04/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/02/2016
• Supplement Report FDA Received Date: 01/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1