MAUDE Adverse Event Report: STRYKER SPINE-FRANCE OASYS 4.0 X 22MM PA SCREW MEDIAL; SPINAL INTERLAMINAL FIXATION ORTHOSIS

Catalog Number 48555422

Device Problems Degraded (1153); Mechanical Problem (1384); Difficult to Remove (1528)

Patient Problems No Known Impact Or Consequence To Patient (2692); Not Applicable (3189)

Event Date 06/16/2015

Event Type  malfunction  

Event Description

It was reported that; removal at c3-t1.Removed blockers and rods with ease.Screw drivers stripped out while attempting to remove screws.Went through several drivers- each stripping out.Surgeon attached a small piece of rod and torqued down blocker to attempt to back out screw using the rod.The tulip popped off on 3 out of the 6 screws he used this method.Surgeon drilled more bone down and removed the left over screw shanks.Removal was completed, but with difficulty and instrument and implant failures.30 minutes surgical delay.Purpose of revision surgery to remove hardware - patient requested.

Manufacturer Narrative

Method: device inspection and device history review results: the screw was confirmed visually to have a separated tulip head.Conclusion: the patient had achieved fusion and wanted the implants removed.It was not known if the screws were inserted tightly against the vertebral body and/or bony growth caused the head to be difficult to remove so the cause is multifactorial.

Event Description

It was reported that; removal at c3-t1.Removed blockers and rods with ease.Screw drivers stripped out while attempting to remove screws.Went through several drivers- each stripping out.Surgeon attached a small piece of rod and torqued down blocker to attempt to back out screw using the rod.The tulip popped off on 3 out of the 6 screws he used this method.Surgeon drilled more bone down and removed the left over screw shanks.Removal was completed, but with difficulty and instrument and implant failures.30 minutes surgical delay.Purpose of revision surgery to remove hardware - patient requested.

• Brand Name: OASYS 4.0 X 22MM PA SCREW MEDIAL
• Type of Device: SPINAL INTERLAMINAL FIXATION ORTHOSIS
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer (Section G): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer Contact: irma gamonal ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 4911680
• MDR Text Key: 6053482
• Report Number: 0009617544-2015-00321
• Device Sequence Number: 1
• Product Code: KWP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142741
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 48555422
• Device Lot Number: 133166
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/16/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/06/2013
• 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