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

Catalog Number	48824014
Medical Device Problem Codes	Mechanical Problem (1384); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Injury (2348); No Information (3190)
Date of Event	01/03/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a cervical screw came out of the plate and went through the patients trachea and was spit out by the patient.Surgery was done to remove the second screw.
Additional Manufacturer Narrative
Catalog# 48824014.Method: device history review; complaint history review; risk assessment; results: manufacturing files could not be reviewed due to lack of parts and lot numbers provided.Conclusion: the probable root cause is not determined.
Event or Problem Description
It was reported that a cervical screw came out of the plate and went through the patients trachea and was spit out by the patient.Surgery was done to remove the second screw.

• 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: 6282663
• Report Number: 0009617544-2017-00035
• Device Sequence Number: 13695180
• Product Code: KWQ
• UDI-Device Identifier: 07613252152286
• UDI-Public: (01)07613252152286
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K083562
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2017

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
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/03/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/27/2017
• Supplement Report FDA Received Date: 04/11/2017
• 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
• Patient Age: 75 YR