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

Catalog Number 48590040

Device Problems Break (1069); Difficult to Insert (1316)

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

Event Date 12/17/2013

Event Type  Injury  

Event Description

It was reported that initially the univise implant wouldn't compress due to the different thickness of superior and inferior spinous process.Using the compressor and final tightening the device (2 clicks with torque limiting handle) the surgeon was able to achieve a little more compression but was still not confident.Teeth on smaller sp were still not really engaged into the bone.The surgeon loosened, compressed and final tightened again when the implant broke.

Manufacturer Narrative

Method: device not returned.Results: the univise spinous process fixation plate, 40mm was confirmed to disassemble during surgery by sales rep report and by a picture of the disassembled device provided by the sales rep.However, three requests for return of the device were made and it was not received.Furthermore, no anomalies were identified in the manufacturing files for the reported lot that may have contributed to the event.Additionally it was reported that the superior and inferior spinous processes that the plate was being attached to were of significantly different thickness.The plates were opening and closing properly, however the plates could not fit to the patient anatomy.This led to excessive force being applied to the device and caused disassembly.Conclusion: this issue is related to improper implant selection and patient anatomy.

Event Description

It was reported that initially the univise implant wouldn't compress due to the different thickness of superior and inferior spinous process.Using the compressor and final tightening the device (2 clicks with torque limiting handle) the surgeon was able to achieve a little more compression but was still not confident.Teeth on smaller sp were still not really engaged into the bone.The surgeon loosened, compressed and final tightened again when the implant broke.

• Brand Name: UNIVISE SPINOUS PROCESS FIXATION PLATE, 40MM
• 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: 3570031
• MDR Text Key: 4056391
• Report Number: 3005525032-2014-00012
• 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: User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/17/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 48590040
• Device Lot Number: B34438
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/17/2013
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR