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U.S. Department of Health and Human Services

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

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BIEDERMANN MOTECH GMBH & CO. KG MOSS 100 SYSTEM Back to Search Results
Model Number SCREW Ø6MM LENGHT UNKOWN
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem Foreign Body In Patient (2687)
Event Date 02/23/2021
Event Type  Injury  
Event Description
The patient had very hard sclerotic bone and when placing one pedicle screw without using a tap, the tip of the cannulated screw driver was broken. The surgery continued without delay. When inserting another pedicle screw a tap was used but only for the first 20mm of the screw trajectory. The neck of this screw broke during the final insertion turn with a solid screw driver. As the construct involved multiple pedicle screws, the surgeon decided to leave the shaft of the pedicle screw in the bone and the surgery continued without delay.
 
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Brand NameMOSS 100 SYSTEM
Type of DeviceMOSS 100 SYSTEM
Manufacturer (Section D)
BIEDERMANN MOTECH GMBH & CO. KG
berth-von suttner str. 23
villingen-schwenningen, 78054
GM 78054
Manufacturer Contact
gerd federle
bertha-von-suttner str. 23
villingen-schwenningen, 78054
GM   78054
MDR Report Key11576308
MDR Text Key251424726
Report Number8010944-2021-00002
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeSP
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 NumberSCREW Ø6MM LENGHT UNKOWN
Device Catalogue NumberINFORMATION NOT AVAILABLE
Device Lot NumberINFORMATION NOT AVAILABLE
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/25/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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