MAUDE Adverse Event Report: STRYKER SPINE-FRANCE AVIATOR ASSY THREE LEVEL PLATE SIZE 42; SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS.

Catalog Number 48811342

Device Problems Mechanical Problem (1384); Device Slipped (1584); Device Dislodged or Dislocated (2923)

Patient Problems Injury (2348); No Code Available (3191)

Event Date 05/04/2015

Event Type  Injury  

Event Description

It was reported that patient went in for a chest x-ray and they noticed that 2 screws had backed out.Patient had to have revision surgery.

Manufacturer Narrative

Method: complaint history review; risk assessment; results: manufacturing files could not be reviewed due to lack of parts.The stryker rep did not report the possible reasons for the backout and did not respond to any further communication to clarify the event.Conclusion: the root cause is not determined due to lack of information and returned parts.

Event Description

It was reported that patient went in for a chest x-ray and they noticed that 2 screws had backed out.Patient had to have revision surgery.

• Brand Name: AVIATOR ASSY THREE LEVEL PLATE SIZE 42
• 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: 5721480
• MDR Text Key: 47289214
• Report Number: 0009617544-2016-00225
• Device Sequence Number: 1
• Product Code: KWQ
• UDI-Device Identifier: 07613252152279
• UDI-Public: (01)07613252152279
• 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: 05/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 48811342
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/17/2016
• 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
• Patient Age: 45 YR