MAUDE Adverse Event Report: STRYKER SPINE-FRANCE OASYS 3.5 X 22MM PA SCREW MEDIAL; SPINAL INTERLAMINAL FIXATION ORTHOSIS

Catalog Number 48555322

Device Problems Detachment Of Device Component (1104); Disassembly (1168); Mechanical Problem (1384)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 06/07/2016

Event Type  malfunction  

Event Description

It was reported that; when removing a screw from the t1 vertebrae the tulip head of the screw fell off.The rest of the screw then came out without any harm to the patient.The screw will be sent back to you for further inspection.There was no harm done to the patient.Patient was fused at those levels they were taking the screws out.

Manufacturer Narrative

Method: visual inspection; device history review; complaint history review; risk assesment.Result: the returned device was inspected and it was confirmed that the tulip head was disengaged from the main screw body.Further inspection found deformation on the inner collar on the bottom of the tulip head and on the top of the screw body implying multiple excessive force applied during the removal of the implant.Upon manufacturing history review, no relevant manufacturing issues found.Deformations observed on the inner collar on the bottom of the tulip head and on the top of the screw body implies that multiple excessive force was applied during the removal of the implant.Conclusion: the possible root cause of this event is due to excessive torsional or cantilever force applied onto the implant during the removal process.

Event Description

It was reported that; when removing a screw from the t1 vertebrae the tulip head of the screw fell off.The rest of the screw then came out without any harm to the patient.The screw will be sent back to you for further inspection.There was no harm done to the patient.Patient was fused at those levels they were taking the screws out.

• Brand Name: OASYS 3.5 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: rakshya bista ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 5759563
• MDR Text Key: 49032965
• Report Number: 0009617544-2016-00264
• Device Sequence Number: 1
• Product Code: KWP
• UDI-Device Identifier: 04546540469540
• UDI-Public: (01)04546540469540
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 48555322
• Device Lot Number: 13D294
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/07/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/14/2014
• 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