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.
Additional Manufacturer Narrative
Additional information & correction: patient age: updated to 67 years.
Event or Problem Description
It was reported that the screw was broken post-operatively.The patient underwent revision surgery.
Additional Manufacturer Narrative
Correction: 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.
Event or Problem Description
It was reported that the screw was broken post-operatively.The patient underwent revision surgery.

• 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: 8471113
• Report Number: 0009617544-2019-00035
• Device Sequence Number: 1575787
• 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: 03/29/2019
• 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