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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 7MM TI MULTILOC HUMERAL NAILLEFT/CANN/300MM-STERILE ROD, FIXATION, INTRAMEDULLARY

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OBERDORF SYNTHES PRODUKTIONS GMBH 7MM TI MULTILOC HUMERAL NAILLEFT/CANN/300MM-STERILE ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Catalog Number 04.019.240S
Device Problem No Apparent Adverse Event (3189)
Patient Problems Nerve Damage (1979); Paralysis (1997)
Event Date 01/01/2019
Event Type  Injury  
Manufacturer Narrative
Event date: unknown date in 2019. The investigation could not be completed; no conclusion could be drawn, as no product was received. Based on the information available, it has been determined that no corrective and/or preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on an unknown date, the patient had a radial nerve paralysis as confirmed by the facility. Initially, the patient was implanted with a multiloc humeral nail in question on (b)(6) 2019. There were four (4) multiloc screws used in the proximal locking and three (3) locking screws used on the distal locking. The facility plans a reoperation on (b)(6) 2019 and in the reoperation, a large skin incision will be made and necessary procedures will be done according to the condition of the nerve pathways. This report is for one (1) 7 mm ti multiloc humeral nailleft/cann/300 mm-sterile. This is report 1 of 8 for (b)(4).
 
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Brand Name7MM TI MULTILOC HUMERAL NAILLEFT/CANN/300MM-STERILE
Type of DeviceROD, FIXATION, INTRAMEDULLARY
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS 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 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key8696167
MDR Text Key147908716
Report Number8030965-2019-65241
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K120807
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/13/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number04.019.240S
Device Lot NumberL754519
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/30/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/23/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 06/13/2019 Patient Sequence Number: 1
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