MAUDE Adverse Event Report: AMENDIA, INC. SCREWS; SYSTEM, FACET SCREW SPINAL DEVICE

Device Problems Break (1069); Migration or Expulsion of Device (1395)

Patient Problems Pain (1994); Stenosis (2263)

Event Date 01/22/2016

Event Type  malfunction  

Event Description

A female patient was admitted early this year with complaints of lower left leg pain and lower back pain.The patient had a previous l4-s1 fusion.The work up revealed bilateral broken screws at s1 and the cage migrated in the canal with severe foraminal stenosis.The patient was taken to surgery for revision and removal and replacement of the screws.The patient did well postoperatively and was discharged a few days later.

• Brand Name: SCREWS
• Type of Device: SYSTEM, FACET SCREW SPINAL DEVICE
• Manufacturer (Section D): AMENDIA, INC.; 1755 w. oak pkwy; suite 100; marietta GA 30062
• MDR Report Key: 5440756
• MDR Text Key: 38308895
• Report Number: 5440756
• Device Sequence Number: 1
• Product Code: MRW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/09/2016
• Event Location: Hospital
• Date Report to Manufacturer: 02/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 59 YR