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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
Device Problem Failure to Osseointegrate (1863)
Patient Problem Inadequate Osseointegration (2646)
Event Date 09/29/2020
Event Type  Injury  
Event Description
The patient, as reported, has a history of revision surgeries. The first revision surgery was to replace implants from a company other than biedermann motech. The revision surgery was concluded with no known complaints. The subject revision surgery was to correct a loose screw (screw halo), of the implanted moss 100 system. The surgeon opted to introduce a screw at another site (level). In the process of implanting the screw a tap broke and was removed, reference cmp (b)(4). The surgeon's attempts were unsuccessful and made a judgement call to not continue with any implantation. The patient did not succumb to injuries as a result of the subject revision surgery.
 
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Brand NameMOSS 100 SYSTEM
Type of DeviceMOSS 100 SYSTEM
Manufacturer (Section D)
BIEDERMANN MOTECH GMBH & CO. KG
bertha-von-suttner-strasse 23
villingen-schwenningen, 78054
GM 78054
MDR Report Key10730836
MDR Text Key213039334
Report Number3013248720-2020-00004
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 10/23/2020,09/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/23/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/23/2020
Distributor Facility Aware Date09/29/2020
Event Location Ambulatory Surgical Facility
Date Report to Manufacturer09/30/2020
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: 10/23/2020 Patient Sequence Number: 1
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