MAUDE Adverse Event Report: STRYKER SPINE-FRANCE AVIATOR ASSY THREE LEVEL PLATE SIZE 39; SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS

Catalog Number 48811339

Device Problems Bent (1059); Device Operates Differently Than Expected (2913); Material Deformation (2976)

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

Event Date 06/14/2016

Event Type  malfunction  

Event Description

It was reported that; the locking wing on plate bent upon screw insertion due to wing overhanging the screw hole.

Manufacturer Narrative

Method: risk assesment; result: the plate was confirmed by the stryker rep to have a deformed spring bar.The stryker rep confirmed that no drill guides were used to prepare the screw holes.Conclusion: the cause is not using the recommended drill guides as per the stg.

Event Description

It was reported that; the locking wing on plate bent upon screw insertion due to wing overhanging the screw hole.

• Brand Name: AVIATOR ASSY THREE LEVEL PLATE SIZE 39
• 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: rakshya bista ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 5780352
• MDR Text Key: 49799670
• Report Number: 0009617544-2016-00275
• Device Sequence Number: 1
• Product Code: KWQ
• UDI-Device Identifier: 07613252152262
• UDI-Public: (01)07613252152262
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K1422317
• 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: 06/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 48811339
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/14/2016
• 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