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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

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BIEDERMANN MOTECH GMBH & CO. KG MOSS 100 SYSTEM MOSS 100 PEDICLE SCREW Back to Search Results
Model Number MOSS 100 PEDICLE SCREW
Device Problem Failure to Osseointegrate (1863)
Patient Problem Inadequate Osseointegration (2646)
Event Date 02/17/2021
Event Type  Injury  
Event Description
As reported, the subject revision surgery was to correct 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 DeviceMOSS 100 PEDICLE SCREW
Manufacturer (Section D)
BIEDERMANN MOTECH GMBH & CO. KG
bertha-von-suttner-str. 23
villingen-schwenningen, 78054
GM 78054
MDR Report Key11434445
MDR Text Key238328101
Report Number3013248720-2021-00003
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 03/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/08/2021
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 AVAIABLE
Device Lot NumberINFORMATION NOT AVAIABLE
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/05/2021
Distributor Facility Aware Date02/22/2021
Event Location Hospital
Date Report to Manufacturer02/26/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 03/08/2021 Patient Sequence Number: 1
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