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

Catalog Number	48590040
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Information (3190)
Date of Event	08/09/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; center locking nut was off track, would not lock onto patients spinous process.
Additional Manufacturer Narrative
Device history review; complaint history review; risk assessment.According to the risk file , too little rotational force, half turn not achieved to lock implant plates in position may result in delay to lock plates or a delay to obtain a new implant if the plates are not in the correct orientation after backer card removal.Upon visual and functional analysis of the returned device, no issues were found.As mentioned in surgical technique, when the additional amount of rotation to the inserter inner shaft was applied until the implant orientation is locked, the center locking nut was able to close and lock the plates.It is likely the probable root cause is not enough rotational force was not applied due to which the implant plates were not able to be locked after the backer card removal.
Event or Problem Description
It was reported that; center locking nut was off track, would not lock onto patients spinous process.

• Brand Name: UNIVISE SPINOUS PROCESS FIXATION PLATE, 40MM
• Common Device Name: SPINAL INTERLAMINAL FIXATION ORTHOSIS
• Manufacturer (Section D): STRYKER SPINE-SWITZERLAND; le crêt-du-locle 10 a; -; la chaux-de-fonds 2300 ; CH 2300
• MDR Report Key: 5920690
• Report Number: 3005525032-2016-00103
• Device Sequence Number: 19026260
• Product Code: KWP
• UDI-Device Identifier: 07613327065657
• UDI-Public: (01)07613327065657
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K122509
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2016

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: 48590040
• Device Lot Number: B49092
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/09/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/01/2016
• Supplement Report FDA Received Date: 11/14/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1