MAUDE Adverse Event Report: STRYKER SPINE-US AVIATOR ASSY TWO LEVEL PLATE SIZE 28; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Catalog Number	48811228
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Codes	Discomfort (2330); No Known Impact Or Consequence To Patient (2692)
Date of Event	02/18/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the metal locking ring was fractured.A revision surgery was performed and metal locking ring was removed.
Additional Manufacturer Narrative
Additional information & correction: additional information about patient experience fall added.Date of implant: corrected to (b)(6) 2015.
Event or Problem Description
It was reported that the metal locking ring was fractured.A revision surgery was performed and metal locking ring was removed.Update: additionally, the sales rep reported that the patient did experience a fall.
Additional Manufacturer Narrative
Method: labeling and risk assessment results: the reported event of one plate securing mechanism fracture post-op was confirmed during revision surgery.The explants have not yet been released by the hospital pathology department at the time of this writing.There were no complications in the original surgery which took place in 2015 and the screws were prepared as recommended by the stg and patient was reported to have normal bone quality, did experience a fall, and did not initially fuse.No lot number was provided, so a manufacturing record review could not be performed as the plate remains implanted.Conclusion: per surgical technique guide (stg), these devices are temporary stabilization devices until bone fusion has been achieved.Bone fusion was not achieved in this case.The surgical technique guide also warns against weight/load bearing activities and the patient was reported to have experienced a fall; the probable root cause is due to both of these factors.
Event or Problem Description
It was reported that the metal locking ring was fractured.A revision surgery was performed and metal locking ring was removed.Update: additionally, the sales rep reported that the patient did experience a fall.

• Brand Name: AVIATOR ASSY TWO LEVEL PLATE SIZE 28
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 8420209
• Report Number: 0009617544-2019-00025
• Device Sequence Number: 303513
• Product Code: KWQ
• UDI-Device Identifier: 07613252152187
• UDI-Public: 07613252152187
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K142237
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• 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): 05/15/2019

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: 48811228
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/18/2019
• Supplement Date Received by Manufacturer: 03/28/2019; 04/29/2019
• Initial Report FDA Received Date: 03/14/2019
• Supplement Report FDA Received Date: 04/15/2019; 05/15/2019
• 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: 52 YR
• Patient Weight: 200