MAUDE Adverse Event Report: AMENDIA PEDICLE SCREW; NONE

Lot Number A103547

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/28/2014

Event Type  malfunction  

Event Description

Pedicle screw broke while placing with amendia counter torque in conjunction with final tightening screwdriver.

• Brand Name: PEDICLE SCREW
• Type of Device: NONE
• Manufacturer (Section D): AMENDIA; marietta GA 30062
• MDR Report Key: 3870182
• MDR Text Key: 4457201
• Report Number: MW5036536
• Device Sequence Number: 1
• Product Code: MCV
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: A103547
• Is the Reporter a Health Professional?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 45 YR
• Patient Weight: 118