MAUDE Adverse Event Report: STRYKER SPINE-FRANCE AVIATOR VARIABLE SELF DRILLING SCREW 4X14MM; SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS.

Catalog Number 48824014

Device Problem Device Slipped (1584)

Patient Problem No Code Available (3191)

Event Date 01/17/2016

Event Type  Injury  

Event Description

It was reported that a revision surgery had to be performed because the plate got pulled out at c7.

Manufacturer Narrative

Catalog# 48824014.Method: device history review; complaint history review; risk assessment; results: the ifu specifically states "bone stock compromised by disease, infection or prior implantation which cannot provide adequate support and/or fixation to the devices" the stryker rep reported that the patient had poor bone quality and that this plate was put in where another implant was previously implanted.Conclusion: the probable root cause is likely related to the bone quality.

Event Description

It was reported that a revision surgery had to be performed because the plate got pulled out at c7.

• Brand Name: AVIATOR VARIABLE SELF DRILLING SCREW 4X14MM
• 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: 5429027
• MDR Text Key: 38004555
• Report Number: 0009617544-2016-00054
• Device Sequence Number: 1
• Product Code: KWQ
• UDI-Device Identifier: 07613252152149
• UDI-Public: 07613252152149
• 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: 01/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 48824014
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2016
• 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
• Patient Outcome(s): Required Intervention