MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG MMF SCREWS,2.0X12MM, CROSS-PIN, SELF DRILLING, 4/P; IMPLANT

Catalog Number 50-20362

Device Problem Difficult to Insert (1316)

Patient Problem Tooth Fracture (2428)

Event Date 12/19/2016

Event Type  Injury  

Manufacturer Narrative

Device is not available for evaluation.If additional information is received it will be reported on a supplemental report.Screws have been discarded at the user facility.

Event Description

A sales representative reported that a doctor was inserting a screw and was having trouble getting the screw to go in.It was determined that the tip of the screw broke off.When pulling the screw out they realized that the screw went through the tooth of the patient.The tooth ended up having to be pulled.It was stated that the procedure was completed successfully.

• Brand Name: MMF SCREWS,2.0X12MM, CROSS-PIN, SELF DRILLING, 4/P
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11
• Manufacturer (Section G): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11
• Manufacturer Contact: hans geiger ; boetzingerstr. 41; freiburg D-791-11 ; 76145120
• MDR Report Key: 6227174
• MDR Text Key: 64018849
• Report Number: 0008010177-2017-00003
• Device Sequence Number: 1
• Product Code: DZL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050535
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 50-20362
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/19/2016
• Initial Date FDA Received: 01/05/2017
• 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