MAUDE Adverse Event Report: STRYKER SPINE-FRANCE UNIVISE SPINOUS PROCESS FIXATION PLATE, 40MM; SPINAL INTERLAMINAL FIXATION ORTHOSIS

Model Number	48590040
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/20/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; the customer reported an issue with a 40mm plate.During the case, the implant was placed ready to be fixed.At this point, the surgeon, commented that the device was not compressing properly to fix to the spinous processes when he was rotating the instrument that is used to do so.The case was completed using another of the same implant.There were a couple of minutes surgical delay only.
Additional Manufacturer Narrative
No relevant manufacturing issue were found.The reported issue could not be confirmed.The exact root cause cannot be determined conclusively since the returned device was found functional.
Event or Problem Description
It was reported that; the customer reported an issue with a 40mm plate.During the case, the implant was placed ready to be fixed.At this point, the surgeon, commented that the device was not compressing properly to fix to the spinous processes when he was rotating the instrument that is used to do so.The case was completed using another of the same implant.There were a couple of minutes surgical delay only.

• Brand Name: UNIVISE SPINOUS PROCESS FIXATION PLATE, 40MM
• Common Device Name: SPINAL INTERLAMINAL FIXATION ORTHOSIS
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6719993
• Report Number: 0009617544-2017-00284
• Device Sequence Number: 1246741
• Product Code: KWP
• UDI-Device Identifier: 07613327065657
• UDI-Public: (01)07613327065657
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K122509
• 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): 12/06/2017

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: 48590040
• Device Catalogue Number: 48590040
• Device Lot Number: 165784
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2017
• Initial Date Received by Manufacturer: 06/21/2017
• Supplement Date Received by Manufacturer: 06/21/2017
• Initial Report FDA Received Date: 07/17/2017
• Supplement Report FDA Received Date: 12/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1