MAUDE Adverse Event Report: STRYKER SPINE-FRANCE ES2 INTEGRATED BLADE SCREW SIZE L 5.5X40MM; SPINAL INTERLAMINAL FIXATION ORTHOSIS.

Catalog Number	482804540
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)
Date of Event	11/14/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that at the patients six week follow up appointment it was noticed that a portion of a tab was retained in the patient.They tab snapped above the reduction thread.
Additional Manufacturer Narrative
Risk assessment; device was not returned and the lot# was not provided, therefore device history review and device inspection could not be performed.The possible root cause of the reported event is due to user error - freehand use to remove the blade - deviation from surgical technique.
Event or Problem Description
It was reported that at the patients six week follow up appointment it was noticed that a portion of a tab was retained in the patient.They tab snapped above the reduction thread.

• Brand Name: ES2 INTEGRATED BLADE SCREW SIZE L 5.5X40MM
• Common Device Name: SPINAL INTERLAMINAL FIXATION ORTHOSIS.
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6170093
• Report Number: 0009617544-2016-00494
• Device Sequence Number: 966663
• Product Code: KWP
• UDI-Device Identifier: 07613327002133
• UDI-Public: (01)07613327002133
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2017

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: 482804540
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/16/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/13/2016
• Supplement Report FDA Received Date: 02/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR