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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG MMF SCREWS, 2.0X12MM, CROSS-PIN, SELF DRILLING, 1/P, STERILE; IMPLANT
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STRYKER LEIBINGER FREIBURG MMF SCREWS, 2.0X12MM, CROSS-PIN, SELF DRILLING, 1/P, STERILE; IMPLANT Back to Search Results
Catalog Number 21-20362
Device Problems Loosening of Implant Not Related to Bone-Ingrowth (4002); Migration (4003)
Patient Problem Discomfort (2330)
Event Date 08/03/2023
Event Type  malfunction  
Event Description
It was reported that the customer found the mmf screws were loose as if they ere not holding in place.It is not known at this time if there will be or has been a revision surgery to fix the loose screws.No other information is known at this time.
 
Manufacturer Narrative
The device has not yet been received at the manufacturer for testing.An evaluation will be conducted upon receipt of the device, and a follow-up report will be submitted after the quality investigation is complete.
 
Manufacturer Narrative
Corrected: further evaluation of initial information revealed, that four patients were affected and it is therefore required to address this in separate complaints.This reported case is now documented / covered under (b)(4), complaint (b)(4) and the reported 0008010177-2023-00060 covers the complaint record.
 
Event Description
It was reported that the customer found the mmf screws were loose as if they ere not holding in place.It is not known at this time if there will be or has been a revision surgery to fix the loose screws.No other information is known at this time.
 
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Brand Name
MMF SCREWS, 2.0X12MM, CROSS-PIN, SELF DRILLING, 1/P, STERILE
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 Key17740759
MDR Text Key323419709
Report Number0008010177-2023-00060
Device Sequence Number1
Product Code DZL
UDI-Device Identifier07613154716302
UDI-Public07613154716302
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K050535
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 12/01/2023
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? Yes
Device Operator Health Professional
Device Catalogue Number21-20362
Device Lot Number1000518701
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 08/03/2023
Initial Date FDA Received09/13/2023
Supplement Dates Manufacturer Received08/03/2023
Supplement Dates FDA Received12/01/2023
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 Number1
Patient Outcome(s) Required Intervention;
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