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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 TI ROD Ø5,5 CURVED

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BIEDERMANN MOTECH GMBH & CO. KG MOSS 100 SYSTEM MOSS 100 TI ROD Ø5,5 CURVED Back to Search Results
Model Number MOSS 100 TI ROD Ø5,5 CURVED
Device Problem No Apparent Adverse Event (3189)
Patient Problem Intervertebral Disc Compression or Protrusion (4524)
Event Date 03/02/2021
Event Type  Injury  
Event Description
It was reported the subject revision surgery was to widen the decompression. Two moss 100 ti locking caps, and one moss 100 ti rod 5. 5 curved (unknown size) were replaced. There were no reported delays to the procedure and no impact to 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 TI ROD Ø5,5 CURVED
Manufacturer (Section D)
BIEDERMANN MOTECH GMBH & CO. KG
bertha-von-suttner str.23
villingen-schweningen, 78054
GM 78054
Manufacturer Contact
gerd federle
bertha-von-suttner str.23
villingen-schwenningen 78054
0049772085
MDR Report Key11618052
MDR Text Key243918074
Report Number8010944-2021-00003
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 04/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/06/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMOSS 100 TI ROD Ø5,5 CURVED
Device Catalogue NumberUNKOWN
Device Lot NumberUNKOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
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 Unkown

Patient Treatment Data
Date Received: 04/06/2021 Patient Sequence Number: 1
Treatment
MOSS 100 TI LOCKING CAPS
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