MAUDE Adverse Event Report: STRYKER SPINE-FRANCE AVIATOR ASSY ONE LEVEL PLATE SIZE 12; SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS.

Catalog Number 48811112

Device Problems Peeled/Delaminated (1454); Material Deformation (2976); Material Integrity Problem (2978); Material Protrusion/Extrusion (2979)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/23/2017

Event Type  malfunction  

Event Description

It was reported that the metal on the plate peeled back around the screw hole and the locking mechanism popped out from under the final tightener.

Manufacturer Narrative

Results: visual, dimensional and functional analysis could not be performed as the device was not returned.Manufacturing files could not be reviewed because no lot number was provided.The rep reported that the holes were prepared using a freehand method and not with the drill guides.The surgical technique guide states that the variable or fixed drill guide should be used to ensure the proper angulation of the screw so as not to damage the spring bar.Conclusion: the probable root cause is user error.

Event Description

It was reported that the metal on the plate peeled back around the screw hole and the locking mechanism popped out from under the final tightener.

• Brand Name: AVIATOR ASSY ONE LEVEL PLATE SIZE 12
• Type of Device: SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS.
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer (Section G): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer Contact: christa marrow ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 6501559
• MDR Text Key: 73250841
• Report Number: 0009617544-2017-00153
• Device Sequence Number: 1
• Product Code: KWQ
• UDI-Device Identifier: 7613252152101
• UDI-Public: (01)7613252152101
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083562
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 48811112
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1