MAUDE Adverse Event Report: STRYKER SPINE-US OASYS 3.5X30MM POLYAXIAL SCREW; POSTERIOR CERVICAL SCREW SYSTEM

Model Number	48552330
Medical Device Problem Codes	Material Separation (1562); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/17/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an oasys polyaxial screw ¿ biased angle tulip disengaged intra-operatively.Surgery was successfully completed without surgical delay using a replacement screw.There were no adverse consequences to the patient.
Event or Problem Description
It was reported that an oasys polyaxial screw ¿ biased angle tulip disengaged intra-operatively.Surgery was successfully completed without surgical delay using a replacement screw.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
Visual, dimensional, functional, and material analysis could not be performed because the device was not returned for evaluation.Device history records were reviewed and no relevant manufacturing issues were identified.Complaint history was reviewed and no similar complaints were found.A root cause cannot be determined without device evaluation.

• Brand Name: OASYS 3.5X30MM POLYAXIAL SCREW
• Common Device Name: POSTERIOR CERVICAL SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 9938037
• Report Number: 0009617544-2020-00062
• Device Sequence Number: 19457125
• Product Code: NKG
• UDI-Device Identifier: 07613154129867
• UDI-Public: 07613154129867
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: K151755
• 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): 07/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 48552330
• Device Catalogue Number: 48552330
• Device Lot Number: 153190
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/12/2020
• Supplement Date Received by Manufacturer: 06/22/2020
• Initial Report FDA Received Date: 04/08/2020
• Supplement Report FDA Received Date: 07/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1