MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND UNIVISE SPINOUS PROCESS FIXATION PLATE, 35MM; SPINAL INTERLAMINAL FIXATION ORTHOSIS

Catalog Number	48590035
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/27/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; dr.Was attempting to put the plate on, he was tightening the plate onto the spinous process with the inserter inner shaft, however he was meeting resistance after only a few turns and the spikes had not even engaged the spinous process yet.The doctor pulled the inserter and implant out, he had the tech reattach the plate to the inserter, and tried again.Dr met tactile resistance again after only a few turns and implant still was not engaging.Dr.Repeated the same steps with the tech readjusting the implant, i watched the tech load the implant all three times, the implant was arrow to arrow, and flush with inserter.The dr.'s 3rd attempt, the same resistance was met, we also switched to a second univise inserter at this point.The doctor asked me for a new implant, so i gave him one.He attempted to put the new implant in, same resistance was met, dr.Pulled the implant and inserter out, loosened up the innershaft all the way, then started tightening it down outside the body, and it worked fine, loosened inner shaft again, put implant in, worked just fine.
Additional Manufacturer Narrative
Method: visual inspection; device history review; complaint history review; risk assessment; results: the reported event implies that the inner shaft of the inserter was probably misaligned with the implant, which resulted difficulty in tightening implant onto the spinous processes.The sales rep stated that the tightening of implant worked fine after loosening the inner shaft from the implant and retightening it again.Conclusion: the probable root cause of this event is user error: innershaft improperly aligned.
Event or Problem Description
It was reported that; dr.Was attempting to put the plate on, he was tightening the plate onto the spinous process with the inserter inner shaft, however he was meeting resistance after only a few turns and the spikes had not even engaged the spinous process yet.The doctor pulled the inserter and implant out, he had the tech reattach the plate to the inserter, and tried again.Dr met tactile resistance again after only a few turns and implant still was not engaging.Dr.Repeated the same steps with the tech readjusting the implant, i watched the tech load the implant all three times, the implant was arrow to arrow, and flush with inserter.The dr.'s 3rd attempt, the same resistance was met, we also switched to a second univise inserter at this point.The doctor asked me for a new implant, so i gave him one.He attempted to put the new implant in, same resistance was met, dr.Pulled the implant and inserter out, loosened up the innershaft all the way, then started tightening it down outside the body, and it worked fine, loosened inner shaft again, put implant in, worked just fine.

• Brand Name: UNIVISE SPINOUS PROCESS FIXATION PLATE, 35MM
• 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: 5680453
• Report Number: 3005525032-2016-00059
• Device Sequence Number: 880069
• Product Code: KWP
• UDI-Device Identifier: 07613327065640
• UDI-Public: (01)07613327065640
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 04/27/2016

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: 48590035
• Device Lot Number: B49093
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/27/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/25/2016
• Supplement Report FDA Received Date: 07/19/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR