MAUDE Adverse Event Report: STRYKER SPINE-US OASYS 4.0 X 42MM POLYAXIAL SCREW; ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION

Catalog Number	48552442
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Injury (2348); No Code Available (3191)
Date of Event	06/01/2013
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the screw on one side was broken post-operatively.Additionally the patient also presented a slip on c4/c5 post-operatively.The patient underwent revision surgery on (b)(6) 2019 for replacement of screw and extension of treatment section.
Additional Manufacturer Narrative
Method: labelling review and risk assessment.Visual, dimensional, functional and materials analysis could not be performed as the device was not returned.It was reported that a revision surgery occurred to extend the construct and replace the broken screw.Manufacturing records for this product were not reviewed because no lot was provided.It was reported that there were no complications in the initial surgery and details on how the screw holes were prepared were not provided.Patient information such as: height, weight, bone fusion, bone quality were not available.The probable root cause is undetermined.Potential root causes can be: 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.Several attempts made for product return but not provided.
Event or Problem Description
It was reported that the screw on one side was broken post-operatively.Additionally the patient also presented a slip on c4/c5 post-operatively.The patient underwent revision surgery on (b)(6) 2019 for replacement of screw and extension of treatment section.

• Brand Name: OASYS 4.0 X 42MM POLYAXIAL SCREW
• Common Device Name: ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 8383582
• Report Number: 0009617544-2019-00016
• Device Sequence Number: 2170908
• Product Code: NKG
• UDI-Device Identifier: 04546540371867
• UDI-Public: 04546540371867
• Combination Product (Y/N): N
• PMA/510(K) Number: K151755
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2019

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: 48552442
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/04/2019
• Supplement Date Received by Manufacturer: 04/30/2019
• Initial Report FDA Received Date: 03/01/2019
• Supplement Report FDA Received Date: 05/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1