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

Catalog Number	48811114
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/10/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It is reported that upon attempting to insert screw into the plate the locking mechanism failed and no longer would lock.Surgeon just used another plate of the same size.No adverse consequences and no surgical delay reported.
Additional Manufacturer Narrative
The reported event was confirmed via correspondence with the rep.The plate was reported disposed prior to the representative being able to retrieve it.Product inspection was not completed as no product was returned (disposed of by the hospital).Product history review was not completed as no lot was provided.According to the surgical technique: "use of the screw hole preparation instruments including the fixed or variable drill guides, all-in-one drill guides or punch awl with sleeves is required to place screws in the proper trajectory, help prevent damage to implants, difficulty locking the blocker, or locking mechanism malfunction." the holes were prepared freehand and not with the drill guides as recommended by the surgical technique guide, so the probable root cause is not using the drill guides as instructed.
Event or Problem Description
It is reported that upon attempting to insert screw into the plate the locking mechanism failed and no longer would lock.Surgeon just used another plate of the same size.No adverse consequences and no surgical delay reported.

• Brand Name: AVIATOR ASSY ONE LEVEL PLATE SIZE 14
• Common Device Name: SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS.
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7572707
• Report Number: 0009617544-2018-00129
• Device Sequence Number: 2062680
• Product Code: KWQ
• UDI-Device Identifier: 07613252152118
• UDI-Public: 07613252152118
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K142237
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2018

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: No Information
• Device Catalogue Number: 48811114
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/10/2018
• Supplement Date Received by Manufacturer: 07/20/2018
• Initial Report FDA Received Date: 06/06/2018
• Supplement Report FDA Received Date: 08/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1