MAUDE Adverse Event Report: STRYKER SPINE-FRANCE OASYS 3.5 X 28MM PA SCREW SMOOTH SHANK; SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS.

Catalog Number	48556328
Medical Device Problem Codes	Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Codes	Injury (2348); No Code Available (3191)
Date of Event	02/23/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had a c1-c4 fixation in (b)(6) 2016 with smooth shank screws at c1 and biased angle screws bilaterally at c3 and c4.Surgery was to stabilise a lytic lesion at c2.The patient reappeared to the surgeon this week with both c1 screws snapped at the point between the smooth shank and the threaded part of the screw.Revision surgery has been undertaken, which involved removal of the top broken screws and extension to the occiput.
Additional Manufacturer Narrative
Method: visual inspection; material analysis; device history review; complaint history review; risk assessment; results: manufacturing records for this product were reviewed and no anomalies were found.Material analysis was performed and found that the fracture type for each screw was unable to be determined due to the extensive post fracture damage on the surface.Conclusion: the root cause is not determined and multifactorial.
Event or Problem Description
It was reported that the patient had a c1-c4 fixation in (b)(6) 2016 with smooth shank screws at c1 and biased angle screws bilaterally at c3 and c4.Surgery was to stabilise a lytic lesion at c2.The patient reappeared to the surgeon this week with both c1 screws snapped at the point between the smooth shank and the threaded part of the screw.Revision surgery has been undertaken, which involved removal of the top broken screws and extension to the occiput.

• Brand Name: OASYS 3.5 X 28MM PA SCREW SMOOTH SHANK
• Common Device Name: SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS.
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6427464
• Report Number: 0009617544-2017-00110
• Device Sequence Number: 648059
• Product Code: KWP
• UDI-Device Identifier: 04546540469731
• UDI-Public: (01)04546540469731
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K032394
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Catalogue Number: 48556328
• Device Lot Number: 137134
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/23/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/23/2017
• Supplement Report FDA Received Date: 06/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention