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

Catalog Number	48824014
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/17/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery had to be performed because the plate got pulled out at c7.
Additional 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 or Problem 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
• Common Device Name: SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS.
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 5429027
• Report Number: 0009617544-2016-00054
• Device Sequence Number: 18969963
• Product Code: KWQ
• UDI-Device Identifier: 07613252152149
• UDI-Public: 07613252152149
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K083562
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Catalogue Number: 48824014
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/18/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/10/2016
• Supplement Report FDA Received Date: 06/10/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention