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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH QUARTER-TUBULAR PLATE WITH COLLAR 6 HOLES/47MM APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, SINGLE COMPONENT

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OBERDORF SYNTHES PRODUKTIONS GMBH QUARTER-TUBULAR PLATE WITH COLLAR 6 HOLES/47MM APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, SINGLE COMPONENT Back to Search Results
Catalog Number 242.06
Device Problem Break (1069)
Patient Problems Failure of Implant (1924); Pain (1994); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. Pma/510k: device is not distributed in the united states, but is similar to device marketed in the usa. Without a lot number the device history records review could not be completed. Product was not returned. 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. (b)(4). 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, that the patient experienced post-op pain due to a broken plate. On (b)(6) 2019 the patient had an open reduction internal fixation (orif) procedure for a right second metacarpal fracture. During the procedure a 1/3 tubular plate and six (6) screws were implanted. Approximately, four (4) weeks after the procedure the patient experienced pain and it was discovered that the plate was broken. On (b)(6) 2020 the patient had an orif revision surgery and received a new plate and screws. The patient was reported as safe and was experiencing slow recovery. Concomitant devices reported: cortscr ø2. 7 l12 sst (part number 202. 012, lot unknown, quantity 2) screws (part number unknown, lot unknown, quantity 4). This report involves one (1) ¼-tub-pl 2. 7 6ho l50 sst. This is report 1 of 1 for (b)(4).
 
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Brand NameQUARTER-TUBULAR PLATE WITH COLLAR 6 HOLES/47MM
Type of DeviceAPPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, SINGLE COMPONENT
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
WERK BETTLACH (CH)
muracherstrasse 3
bettlach CO 2544
SZ 2544
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key10385728
MDR Text Key203744521
Report Number8030965-2020-05833
Device Sequence Number1
Product Code KTW
Combination Product (y/n)N
Reporter Country CodeCY
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 07/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/10/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number242.06
Device Lot Number2031198
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/14/2020
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/10/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/09/2002
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: 08/10/2020 Patient Sequence Number: 1
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