MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG MMF SCREWS, 2.0X8MM, CROSS-PIN, SELF DRI; IMPLANT

Catalog Number 21-20358

Device Problem Migration (4003)

Patient Problem Discomfort (2330)

Event Date 08/03/2023

Event Type  Injury  

Manufacturer Narrative

Device is not available for evaluation.If additional information is received it will be reported on a supplemental report.H3 other text : implanted.

Event Description

It was reported there was a revision surgery performed to revise and tighten the screws.

Manufacturer Narrative

The device under complaint has not been returned and further details were not provided, no profound investigation could be performed, and therewith, no detailed determination of the root cause is possible.

Event Description

It was reported there was a revision surgery performed to revise and tighten the screws.

• Brand Name: MMF SCREWS, 2.0X8MM, CROSS-PIN, SELF DRI
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer (Section G): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer Contact: rylee koole ; boetzingerstr. 41; freiburg D-791-11 ; GM D-79111 ; 7614888208
• MDR Report Key: 17969734
• MDR Text Key: 326095960
• Report Number: 0008010177-2023-00063
• Device Sequence Number: 1
• Product Code: DZL
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K050535
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 21-20358
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/03/2023
• 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
• Patient Outcome(s): Required Intervention