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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH THREAD-ROD Ø14 L330 F/LARGE-DISTRACT APPARATUS, TRACTION, NON-POWERED

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SYNTHES GMBH THREAD-ROD Ø14 L330 F/LARGE-DISTRACT APPARATUS, TRACTION, NON-POWERED Back to Search Results
Catalog Number 394.41
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/01/2022
Event Type  malfunction  
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Brand NameTHREAD-ROD Ø14 L330 F/LARGE-DISTRACT
Type of DeviceAPPARATUS, TRACTION, NON-POWERED
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
WERK BETTLACH (CH)
muracherstrasse 3
bettlach
Manufacturer Contact
kate karberg
eimattstrasse 3
oberdorf 
SZ  
6103142063
MDR Report Key15129229
Report Number8030965-2022-05396
Device Sequence Number1
Product Code HST
Combination Product (y/n)N
Reporter Country CodeCO
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/29/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number394.41
Device Lot Number54P5457
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/01/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/12/2020
Is the Device Single Use? No
Type of Device Usage Unkown

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