MAUDE Adverse Event Report: STRYKER LEIBINGER LEIBINGER UNIVERSAL MANDIBLE SET; BONE SCREW

Model Number 50-20414

Device Problems Break (1069); Component Falling (1105)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/17/2018

Event Type  malfunction  

Event Description

Surgeon was in the process of fixing a mandible fracture when one of the screw heads broke off.The shaft of the screw remains in the left mandible of patient.

• Brand Name: LEIBINGER UNIVERSAL MANDIBLE SET
• Type of Device: BONE SCREW
• Manufacturer (Section D): STRYKER LEIBINGER; 750 trade centre way ste 200; portage MI 49002
• MDR Report Key: 7361324
• MDR Text Key: 103170392
• Report Number: 7361324
• Device Sequence Number: 1
• Product Code: JEY
• 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: 03/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 50-20414
• Device Catalogue Number: 50-20414
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/20/2018
• Device Age: 1 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/20/2018
• 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 Age: 26 YR