MAUDE Adverse Event Report: STRYKER SPINE-FRANCE OASYS POLYAXIAL SCREW NON BIASED DIA 3.5 X 12; SPINAL INTERLAMINAL FIXATION ORTHOSIS

Model Number	48558312
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Codes	Failure of Implant (1924); Injury (2348)
Date of Event	10/12/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that; doctor had to remove post cervical screw right c3 lateral mass screw.After looking at xrays the images revealed that the rod and screw disassociated.Doctor removed set screw and then removed the lateral mass screw.While attempting to remove the tulip popped off of the shaft.Doctor then used instrument to back out shaft and cut the rod above right c4 screw.Doctor checked other screws to confirm set screws were tightened sufficiently.This was noticed by surgeon's pa, the patient was complaining of squeaking sounds in neck.This was from a prior surgery date is unknown, thought it was end (b)(6).
Additional Manufacturer Narrative
Method: visual inspection, device history review, complaint history review, risk assessment.Result: the tulip was confirmed to be separated from the screw shank via visual inspection.Manufacturing records for this product were reviewed and no anomalies were found.There were no other occurrences for the reported product lot.The plausible root cause is tissue ingrowth of the implanted screw.
Event or Problem Description
It was reported that; doctor had to remove post cervical screw right c3 lateral mass screw.After looking at xrays the images revealed that the rod and screw disassociated.Doctor removed set screw and then removed the lateral mass screw.While attempting to remove the tulip popped off of the shaft.Doctor then used instrument to back out shaft and cut the rod above right c4 screw.Doctor checked other screws to confirm set screws were tightened sufficiently.This was noticed by surgeon's pa, the patient was complaining of squeaking sounds in neck.This was from a prior surgery date is unknown, thought it was end (b)(6) 2017.

• Brand Name: OASYS POLYAXIAL SCREW NON BIASED DIA 3.5 X 12
• Common Device Name: SPINAL INTERLAMINAL FIXATION ORTHOSIS
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 7008938
• Report Number: 0009617544-2017-00399
• Device Sequence Number: 13615353
• Product Code: KWP
• UDI-Device Identifier: 04546540596314
• UDI-Public: (01)04546540596314
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: K151755
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2018

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 Model Number: 48558312
• Device Catalogue Number: 48558312
• Device Lot Number: 16E023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2017
• Initial Date Received by Manufacturer: 10/12/2017
• Supplement Date Received by Manufacturer: 01/29/2018
• Initial Report FDA Received Date: 11/08/2017
• Supplement Report FDA Received Date: 02/24/2018
• 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
• Patient Age: 73 YR