MAUDE Adverse Event Report: STRYKER SPINE-US OASYS 4.0 X 42MM POLYAXIAL SCREW; POSTERIOR CERVICAL SCREW SYSTEM

Catalog Number	48552442
Health Effect - Clinical Code	Injury (2348)
Date of Event	02/08/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Physician reported that an oasys polyaxial screw meant to correct an odontoid fracture and atlantoaxial subluxation at c1-c2, fractured in (b)(6) of 2013.The patient was not revised for this issue.
Additional Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the device was not returned.Device and complaint history records review could not be performed as a valid lot code was not provided and could not be obtained.Per surgical technique: while the expected life of spinal implant components is difficult to estimate, it is finite.The surgeon must warn the patient that the device cannot and does not replicate the flexibility, strength, reliability or durability of normal healthy bone, that the implant can break or become damaged as a result of strenuous activity or trauma, and that the device may need to be replaced in the future.These implants are temporary internal fixation devices designed to stabilize the operative site during the normal healing process.After healing occurs, these devices serve no functional purpose and can be removed.The actual root cause cannot be determined, possible root causes include: -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
Physician reported that an oasys polyaxial screw meant to correct an odontoid fracture and atlantoaxial subluxation at c1-c2, fractured in (b)(6) of 2013.The patient was not revised for this issue.

• Brand Name: OASYS 4.0 X 42MM POLYAXIAL SCREW
• Common Device Name: POSTERIOR CERVICAL SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 9379676
• Report Number: 0009617544-2019-00126
• Device Sequence Number: 16749932
• 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: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2020

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 Catalogue Number: 48552442
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/28/2019
• Supplement Date Received by Manufacturer: 12/27/2019
• Initial Report FDA Received Date: 11/26/2019
• Supplement Report FDA Received Date: 01/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR