MAUDE Adverse Event Report: STRYKER SPINE-FRANCE OASYS 4.0 X 20MM PA SCREW MEDIAL; SPINAL INTERLAMINAL FIXATION ORTHOSIS

Catalog Number 48555420

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

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

Event Date 04/30/2015

Event Type  malfunction  

Event Description

It was reported by stryker sales rep, that he was present during a surgery at (b)(6) hospital when the following event occurred: "the hex end on an oasys screw head became burred and rounded which meant that the screw could not be fully inserted or taken out.Efforts were made to extract the screw with various tools and techniques, but none of them were successful." it was further reported that the procedure was completed and the construct locked down with the screw 5mm higher than planned.

Manufacturer Narrative

Method: device not returned.Results: device was not returned.Manufacturing files could not be reviewed because no lot number was provided.Conclusion: the root cause is not known due to lack of information.

Event Description

It was reported by stryker sales rep, that he was present during a surgery at royal gwent hospital when the following event occurred: "the hex end on an oasys screw head became burred and rounded which meant that the screw could not be fully inserted or taken out.Efforts were made to extract the screw with various tools and techniques, but none of them were successful." it was further reported that the procedure was completed and the construct locked down with the screw 5mm higher than planned.

• Brand Name: OASYS 4.0 X 20MM PA SCREW MEDIAL
• Type of Device: SPINAL INTERLAMINAL FIXATION ORTHOSIS
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 3361 0; FR 33610
• Manufacturer (Section G): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 3361 0; FR 33610
• Manufacturer Contact: irma gamonal ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 4796155
• MDR Text Key: 5856019
• Report Number: 0009617544-2015-00234
• Device Sequence Number: 1
• Product Code: KWP
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K150539
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 48555420
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/30/2015
• 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