MAUDE Adverse Event Report: STRYKER SPINE-US AVIATOR ASSY ONE LEVEL PLATE SIZE 14; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Catalog Number	48811114
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	02/06/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that locking ring on plate broke off.All broken fragments were retrieved.A surgical delay of a minute or two was reported.The plate was left in the patient.No adverse consequences to the patient was reported at this time.This will be reported due to the possibility of screw pull out in the future.
Additional Manufacturer Narrative
Labelling review and risk assessment.Visual, dimensional, functional and materials analysis could not be performed as the device remains implanted in patient.It was confirmed during surgery that the plate securing mechanism broke intra-op.It was reported that the surgeon decided to use the same plate which remains implanted in the patient.Manufacturing record review and complaint history review could not be performed because lot number was not provided.It was reported that the variable drill guides were used, the plate was inspected prior to surgery, and was placed and removed once before final placement it appears that the surgical technique was followed, so the potential causes may be: - excessive torsional force/cantilever force applied - screw not fully seated below spring-bar - stripped screw head/screwdriver tip however a definite root cause cannot be determined at this time.Intra-operative precautions ¿ the insertion of the implants must be carried out using instruments designed and provided for this purpose and in accordance with the specific implantation instructions for each implant.Those detailed instructions are provided in the surgical technique brochure supplied by stryker spine.¿ discard all damaged or mishandled implants.¿ stryker spine implants must not be reshaped, unless otherwise indicated in the surgical technique instructions.When implants need to be bent, the bending must be carried out gradually using the appropriate instruments, provided by stryker spine.The use of inappropriate instruments may result in scratches, notches, and sharp bending, causing the breakage of the implants.Improper seating of the implant may result in implant failure.¿ never reuse an implant, even though it may appear undamaged.¿ do not mix metals.
Event or Problem Description
It was reported that locking ring on plate broke off.All broken fragments were retrieved.A surgical delay of a minute or two was reported.The plate was left in the patient.No adverse consequences to the patient was reported at this time.This will be reported due to the possibility of screw pull out in the future.

• Brand Name: AVIATOR ASSY ONE LEVEL PLATE SIZE 14
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 8392080
• Report Number: 0009617544-2019-00020
• Device Sequence Number: 10867802
• Product Code: KWQ
• UDI-Device Identifier: 07613252152118
• UDI-Public: 07613252152118
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K142237
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 48811114
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/06/2019
• Supplement Date Received by Manufacturer: 04/30/2019
• Initial Report FDA Received Date: 03/05/2019
• 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
• Patient Age: 61 YR