MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG MMF SCREWS, 2.0X8MM, CROSS-PIN, SELF DRILLING, 4/P; IMPLANT

Catalog Number 50-20358

Device Problems Retraction Problem (1536); Device Operates Differently Than Expected (2913)

Patient Problem Failure of Implant (1924)

Event Date 04/25/2017

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 were discarded at the user facility.

Event Description

A sales representative reported that 2 screws have retracted/stripped within a patient post operatively.The retraction of these screws caused an additional procedure to take place for the patient.

• Brand Name: MMF SCREWS, 2.0X8MM, 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: 6583204
• MDR Text Key: 75701974
• Report Number: 0008010177-2017-00110
• 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: 05/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 50-20358
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/25/2017
• 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