MAUDE Adverse Event Report: STRYKER SPINE-US OASYS 3.5 X 240MM ROD; POSTERIOR CERVICAL SCREW SYSTEM

Catalog Number	48552240
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Date of Event	02/08/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Physician reported an oasys 3.5 x 240 mm rod fractured post-operatively.Revision surgery has been scheduled for (b)(6) 2019.
Event or Problem Description
Physician reported an oasys 3.5 x 240 mm rod fractured post-operatively.Revision surgery has been scheduled for (b)(6) 2019.
Additional Manufacturer Narrative
Corrected data: updated outcomes attributed to adverse event from no selection to 'required intervention to prevent permanent impairment/damage (device).' updated device evaluated by mfr to 'status and location of the device are unknown.' status and location of the device are unknown.
Event or Problem Description
Physician reported an oasys 3.5 x 240 mm rod fractured post-operatively.Revision surgery has occurred.
Additional Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the device was not returned.Device and complaint history records were reviewed, and no relevant manufacturing or similar complaints were identified.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.

• Brand Name: OASYS 3.5 X 240MM ROD
• Common Device Name: POSTERIOR CERVICAL SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 9379807
• Report Number: 0009617544-2019-00128
• Device Sequence Number: 3067190
• Product Code: NKG
• UDI-Device Identifier: 04546540371652
• UDI-Public: 04546540371652
• 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,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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 48552240
• Device Lot Number: VL7
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/28/2019
• Supplement Date Received by Manufacturer: 12/09/2019; 12/27/2019
• Initial Report FDA Received Date: 11/26/2019
• Supplement Report FDA Received Date: 12/30/2019; 01/17/2020
• 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: 72 YR