MAUDE Adverse Event Report: STRYKER SPINE-FRANCE AVIATOR ASSY TWO LEVEL PLATE SIZE 34; SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS

Catalog Number 48811234

Device Problems Device Damaged by Another Device (2915); Material Deformation (2976)

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

Event Date 09/13/2016

Event Type  malfunction  

Event Description

It was reported that the cervical plate was being used.The locking nut was engaged on the plate causing the spring bar to be damaged upon screw insertion.Another 34mm plate was used.Screw is still stuck in plate.

Manufacturer Narrative

Method: visual inspection, device history review, complaint history review, risk assessment; result: the device was confirmed visually to have a deformed spring bar.Manufacturing files were reviewed and no anomalies were found.Conclusion: the cause is not using the recommended drill guides as per the stg.

Event Description

It was reported; that the cervical plate was being used.The locking nut was engaged on the plate causing the spring bar to be damaged upon screw insertion.Another 34mm plate was used.Screw is still stuck in plate.

• Brand Name: AVIATOR ASSY TWO LEVEL PLATE SIZE 34
• 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: 6015102
• MDR Text Key: 57427953
• Report Number: 0009617544-2016-00405
• Device Sequence Number: 1
• Product Code: KWQ
• UDI-Device Identifier: 07613252152217
• UDI-Public: (01)07613252152217
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 48811234
• Device Lot Number: 160332
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/21/2016
• 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