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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIEDERMANN MOTECH GMBH & CO. KG MOSS 100 SYSTEM MOSS100 SYSTEM

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BIEDERMANN MOTECH GMBH & CO. KG MOSS 100 SYSTEM MOSS100 SYSTEM Back to Search Results
Model Number MOSS 100 PEDICLE SCREW
Device Problem Patient Device Interaction Problem (4001)
Patient Problem Inadequate Osseointegration (2646)
Event Date 02/17/2021
Event Type  Injury  
Event Description
There was a revision surgery was to replace a loose screw. The surgeon opted to remove the ø7. 0mm screw on the bottom right side, and replace the subject screw with a biedermann ø8. 0mm pedicle screw. Additionally, the upper screws of the construct were removed and replaced with competitor's ø9. 0mm screws. The surgeon was able to complete the surgery without reported delays. There are no reports of impact on the patient's outcome as a result of the revision surgery. Product will not be returned.
 
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Brand NameMOSS 100 SYSTEM
Type of DeviceMOSS100 SYSTEM
Manufacturer (Section D)
BIEDERMANN MOTECH GMBH & CO. KG
bertha-von-suttner str. 23
villingen-schwenningen, 78054
GM 78054
Manufacturer Contact
gerd federle
bertha-von-suttner str. 23
villingen-schwennigen, 78054
GM   78054
MDR Report Key11575470
MDR Text Key242470935
Report Number8010944-2021-00001
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K162232
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 03/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/26/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMOSS 100 PEDICLE SCREW
Device Catalogue NumberINFORMATION NOT AVAILABLE
Device Lot NumberINFORMATION NOT AVAILABLE
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/26/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 03/26/2021 Patient Sequence Number: 1
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