MAUDE Adverse Event Report: STRYKER SPINE-FRANCE OASYS 3.5 X 14MM POLYAXIAL SCREW; SPINAL INTERLAMINAL FIXATION ORTHOSIS.

Catalog Number	48552314
Medical Device Problem Codes	Mechanical Problem (1384); Difficult To Position (1467)
Health Effect - Clinical Codes	Tissue Damage (2104); Injury (2348)
Date of Event	08/02/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an angle screw placed in cervical spine, rod placed on construct, blocker placed, final tightened.X-ray taken, surgeon was unhappy with the screw, therefore wanted to reposition it.The screw was no longer polyaxial and fixed in position, screwdriver unable to engage with screw, or poly adjustment driver.Therefore screw had to be turned and pulled out, damage to joint of cervical bone.Screw inspected by rep, it appears the shank of the screw has been pushed down and almost popped through the tulip head, therefore fixed in position.
Additional Manufacturer Narrative
Device history review; complaint history review; risk assessment; the patient had a cancer of the neck, with a tracheostomy, he had a poor prognosis due to his cancer, bone was a bit softer where the disease has infiltrated the vertebral bodies, but there was a good old on the screws.Manufacturing records for this product were reviewed and no incidents were found.The probable root cause is due to patient pathology.
Event or Problem Description
It was reported that an angle screw placed in cervical spine, rod placed on construct, blocker placed, final tightened.X-ray taken, surgeon was unhappy with the screw, therefore wanted to reposition it.The screw was no longer polyaxial and fixed in position, screwdriver unable to engage with screw, or poly adjustment driver.Therefore screw had to be turned and pulled out, damage to joint of cervical bone.Screw inspected by rep, it appears the shank of the screw has been pushed down and almost popped through the tulip head, therefore fixed in position.

• Brand Name: OASYS 3.5 X 14MM POLYAXIAL SCREW
• Common Device Name: SPINAL INTERLAMINAL FIXATION ORTHOSIS.
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 5884476
• Report Number: 0009617544-2016-00338
• Device Sequence Number: 11140294
• Product Code: KWP
• UDI-Device Identifier: 04546540371683
• UDI-Public: (01)04546540371683
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K032394
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2016

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: 48552314
• Device Lot Number: 15A707
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/02/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/17/2016
• Supplement Report FDA Received Date: 10/28/2016
• 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: Other