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

Catalog Number 48590035

Device Problem Material Separation (1562)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/12/2013

Event Type  malfunction  

Event Description

It was reported that upon implantation, surgeon used a mallet to position the univise implant between the spinous processes.The implant was locked at undesirable angle so he used the inner shaft driver to loosen the implant, repositioned the implant and then proceeded to implant again.Once the surgeon reached a desired position the surgeon used the inner shaft to compress the implant.But the implant would not compress the surgeon then removed the implant.As the surgeon inspected the implant for a cause of the issue the implant ended up separating apart into 3 pieces.Another spinious process fixation device was used and the surgery was completed successfully.

• Brand Name: UNIVISE SPINOUS PROCESS FIXATION PLATE, 35MM
• Type of Device: IMPLANT- SPINAL PROCESS FIXATION PLATE
• Manufacturer (Section D): STRYKER SPINE-SWITZERLAND; le crêt-du-locle 10 a; -; la chaux-de-fonds 2300 ; CH 2300
• Manufacturer (Section G): STRYKER SPINE-SWITZERLAND; le crêt-du-locle 10 a; -; la chaux-de-fonds 2300 ; CH 2300
• Manufacturer Contact: daniel roberts ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 3561020
• MDR Text Key: 4055142
• Report Number: 3005525032-2014-00008
• Device Sequence Number: 1
• Product Code: PEK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132968
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/12/2013

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
• Device Operator: Health Professional
• Device Catalogue Number: 48590035
• Device Lot Number: B34436
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/12/2013
• Initial Date FDA Received: 01/08/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1