MAUDE Adverse Event Report: STRYKER SPINE-US OASYS 3.5 X 26MM PA SCREW SMOOTH SHANK; ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION

Catalog Number	48556326
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Codes	Failure of Implant (1924); Injury (2348)
Date of Event	06/22/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the screw was broken post-operatively.The patient underwent revision surgery.
Event or Problem Description
It was reported that the screw was broken post-operatively.The patient underwent revision surgery.
Additional Manufacturer Narrative
The product was not returned to stryker.Visual, dimensional, functional inspection, and material analysis could not be performed as the device was discarded.Complaint history records were not reviewed as a valid lot number was not provided and could not be obtained.Manufacturing history records were not reviewed as a valid lot number was not provided and could not be obtained.It was reported that the threading of the screw shank fractured post-operatively.Root cause could not be determined; however, some potential root causes are: -improper construct, set screws not tightened correctly -excessive load due to unstable construct -excessive load due to patient anatomy/pathology -patient performs strenuous post-op activities -surgeon applying too much torque to seat the screw head h3 other text : device discarded by the hospital.
Event or Problem Description
It was reported that the screw was broken post-operatively.The patient underwent revision surgery.
Additional Manufacturer Narrative
Additional information & correction: patient age: updated to 67 years.

• Brand Name: OASYS 3.5 X 26MM PA SCREW SMOOTH SHANK
• Common Device Name: ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 8471120
• Report Number: 0009617544-2019-00036
• Device Sequence Number: 1962396
• Product Code: NKG
• UDI-Device Identifier: 07613327067606
• UDI-Public: 07613327067606
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K151755
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/02/2019

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: Health Professional
• Device Catalogue Number: 48556326
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 03/29/2018
• Initial Date Received by Manufacturer: 03/06/2019
• Supplement Date Received by Manufacturer: 04/01/2019; 07/15/2019
• Initial Report FDA Received Date: 04/01/2019
• Supplement Report FDA Received Date: 04/08/2019; 08/02/2019
• 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: 67 YR
• Patient Weight: 96