MAUDE Adverse Event Report: AMENDIA SAVANNAH-T; PEDICLE SYSTEM IMPLANT

Device Problem Fracture (1260)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/07/2017

Event Type  malfunction  

Manufacturer Narrative

An investigation into the reported event is ongoing.Any additional information obtained and the results of the investigation will be reported in a follow-up report.

Event Description

The screw broke and the tip remains in the patient's body.

• Brand Name: SAVANNAH-T
• Type of Device: PEDICLE SYSTEM IMPLANT
• Manufacturer (Section D): AMENDIA; 1755 w oak pkwy; marietta GA 30062
• Manufacturer (Section G): AMENDIA; 1755 w oak pkwy; marietta GA 30062
• Manufacturer Contact: bruce hooper ; 1755 w oak pkwy; marietta, GA 30062 ; 6784453784
• MDR Report Key: 6818484
• MDR Text Key: 83683090
• Report Number: 1067095-2017-00017
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132925
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/07/2017
• Initial Date FDA Received: 08/24/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other