MAUDE Adverse Event Report: STRYKER SPINE-FRANCE AVIATOR ASSY TWO LEVEL PLATE SIZE 40; SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS.

Catalog Number 48811240

Device Problems Break (1069); Detachment Of Device Component (1104); Device Slipped (1584)

Patient Problem Pain (1994)

Event Date 01/13/2016

Event Type  Injury  

Event Description

It was reported that primary surgery was performed on (b)(6) 2013.Recently the patient reported neck pain, so x-ray showed a screw backing out and another one broken in left c7.During the removal, surgeon noticed fragments of the top of screws broken off and one of the spring bars was broken off.Patient seems fused.

Manufacturer Narrative

Method: visual inspection; device history review; complaint history review; risk assessment; results: the returned device was confirmed visually to have a fractured spring bar.Manufacturing files were reviewed and no anomalies were found.Conclusion: the plausible root cause of the reported event is not determined and multifactorial.

Event Description

It was reported that primary surgery was performed on (b)(6) 2013.Recently the patient reported neck pain, so x-ray showed a screw backing out and another one broken in left c7.During the removal, surgeon noticed fragments of the top of screws broken off and one of the spring bars was broken off.Patient seems fused.

• Brand Name: AVIATOR ASSY TWO LEVEL PLATE SIZE 40
• 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: 5411640
• MDR Text Key: 37524891
• Report Number: 0009617544-2016-00041
• Device Sequence Number: 1
• Product Code: KWQ
• 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: 01/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 48811240
• Device Lot Number: 108409
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/13/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/16/2010
• 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
• Patient Outcome(s): Required Intervention