MAUDE Adverse Event Report: STRYKER SPINE-FRANCE AVIATOR ASSY ONE LEVEL PLATE SIZE 18; SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS

Catalog Number 48811118

Device Problems Bent (1059); Failure to Advance (2524); Material Deformation (2976)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 03/06/2017

Event Type  malfunction  

Event Description

It was reported that; 18mm plate was implanted & when trying to tighten screws down surgeon was unable to get pass spring bar.End was bent not allowing screw to engage.Plate was removed and new selected with rescue screw used.

Manufacturer Narrative

Visual inspection, device history review, complaint history review, risk assessment.The device was not confirmed to have a deformed spring bar and functional testing revealed a blocker able to be turned.Manufacturing files were reviewed and no anomalies were found.Potential root causes include:-surgeon does not tighten screws properly; - screw hole not properly prepared (too shallow).

Event Description

It was reported that; 18mm plate was implanted & when trying to tighten screws down surgeon was unable to get pass spring bar.End was bent not allowing screw to engage.Plate was removed and new selected with rescue screw used.

• Brand Name: AVIATOR ASSY ONE LEVEL PLATE SIZE 18
• 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: 6455178
• MDR Text Key: 71727102
• Report Number: 0009617544-2017-00118
• Device Sequence Number: 1
• Product Code: KWQ
• UDI-Device Identifier: 07613252152132
• UDI-Public: (01)07613252152132
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142237
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/01/2017

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
• Device Operator: No Information
• Device Catalogue Number: 48811118
• Device Lot Number: 160809
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/06/2017
• Initial Date FDA Received: 04/03/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/01/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/04/2016
• 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