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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH 2.4MM TI VA-LCP VOLAR RIM DSTL RAD PL/7H HD/5H SHFT/LT-STER PLATE, FIXATION, BONE

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SYNTHES GMBH 2.4MM TI VA-LCP VOLAR RIM DSTL RAD PL/7H HD/5H SHFT/LT-STER PLATE, FIXATION, BONE Back to Search Results
Catalog Number 04.115.851S
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/03/2022
Event Type  malfunction  
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Brand Name2.4MM TI VA-LCP VOLAR RIM DSTL RAD PL/7H HD/5H SHFT/LT-STER
Type of DevicePLATE, FIXATION, BONE
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
WERK MEZZOVICO (CH)
via cavazz 5
mezzovico 6805
SZ 6805
Manufacturer Contact
kate karberg
1302 wrights lane east
west chester, PA 19380
8472871282
MDR Report Key13970842
Report Number8030965-2022-02091
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K110125
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/31/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.115.851S
Device Lot Number437P927
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/11/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/03/2021
Is the Device Single Use? Yes
Type of Device Usage Unkown

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