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

Catalog Number 50-20362

Device Problems Break (1069); Difficult to Remove (1528); Detachment of Device or Device Component (2907)

Patient Problem Failure of Implant (1924)

Event Date 07/20/2018

Event Type  malfunction  

Manufacturer Narrative

Device is not available for evaluation.If additional information is received it will be reported on a supplemental report.Screw head was discarded and shaft remains in patient.

Event Description

It was reported by the company representative that the surgeon was performing a mandible insert surgery, and one of the screws broke off.The surgeon opened gum tissue to try to remove the screw shaft but was not able to remove it.Another screw was used to complete the surgery.No significant delay of surgery over 30 minutes reported.

• 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: kelli dykstra ; boetzingerstr. 41; freiburg D-791-11 ; 76145120
• MDR Report Key: 7748340
• MDR Text Key: 116400775
• Report Number: 0008010177-2018-00070
• Device Sequence Number: 1
• Product Code: DZL
• UDI-Device Identifier: 34546540732027
• UDI-Public: 34546540732027
• 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: 08/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 50-20362
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/20/2018
• 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