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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIEDERMANN MOTECH GMBH & CO. KG MOSS 100 SYSTEM; MOSS 100 PEDICLE SCREW SYSTEM
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BIEDERMANN MOTECH GMBH & CO. KG MOSS 100 SYSTEM; MOSS 100 PEDICLE SCREW SYSTEM Back to Search Results
Model Number MOSS 100 PEDICLE SCREW SYSTEM
Device Problem Patient Device Interaction Problem (4001)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 04/09/2021
Event Type  Injury  
Event Description
It was reported a revision surgery was required due to "non-union" (non-integration).It was reported all biedermann hardware was remove from the patient.There were no reports of patient impact as a result of this revision surgery.Product will not be returned.
 
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Brand Name
MOSS 100 SYSTEM
Type of Device
MOSS 100 PEDICLE SCREW SYSTEM
Manufacturer (Section D)
BIEDERMANN MOTECH GMBH & CO. KG
bertha-von-suttner strasse 23
villingen-schwenningen, 78054
GM  78054
Manufacturer Contact
gerd federle
bertha-von-suttner str. 23
villingen-schwenningen, 78054
GM   78054
MDR Report Key11899482
MDR Text Key253138350
Report Number8010944-2021-00004
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 05/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/28/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Model NumberMOSS 100 PEDICLE SCREW SYSTEM
Device Catalogue NumberINFORMATION NOT AVAILABLE
Device Lot NumberINFORMATION NOT AVAILABLE
Was Device Available for Evaluation? No
Date Manufacturer Received04/29/2021
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 Unknown
Patient Sequence Number1
Treatment
INFORMATION NOT AVAILABLE
Patient Outcome(s) Required Intervention;
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