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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH PHN MULTILOC Ø9.5 IZQ CAN L160 TAN ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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SYNTHES GMBH PHN MULTILOC Ø9.5 IZQ CAN L160 TAN ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 04.016.039S
Device Problems Break (1069); Entrapment of Device (1212); Device-Device Incompatibility (2919)
Patient Problem Foreign Body In Patient (2687)
Event Date 02/01/2022
Event Type  malfunction  
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Brand NamePHN MULTILOC Ø9.5 IZQ CAN L160 TAN
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key13653743
Report Number8030965-2022-01293
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K103002
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign
Reporter Occupation
Type of Report Initial,Followup
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/02/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.016.039S
Device Lot Number93P0626
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/28/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/30/2021
Is the Device Single Use? Yes
Type of Device Usage Unkown

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