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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 3.5MM TI LCP PROXIMAL TIBIA PL LOW BEND 14 HOLES/206MM/RIGHT PLATE, FIXATION, BONE

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OBERDORF SYNTHES PRODUKTIONS GMBH 3.5MM TI LCP PROXIMAL TIBIA PL LOW BEND 14 HOLES/206MM/RIGHT PLATE, FIXATION, BONE Back to Search Results
Catalog Number 04.124.220
Device Problem Defective Device (2588)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Product complaint (b)(4). Complainant part returned for manufacturer review/investigation. Reporter is a synthes rep. A review of the device history record has been requested. The investigation could not be completed; no conclusion could be drawn at the time of filing this report. 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 when the distributor did the incoming goods checking, opened the packing, noted the device was with 16 holes, the same as 04. 124. 224 as the photo show, checked the label, it shows 14 holes. There were no adverse consequences to the patient. It was the wrong hole qty. This complaint involves one (1) device. This report is 1 of 1 for (b)(4).
 
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Brand Name3.5MM TI LCP PROXIMAL TIBIA PL LOW BEND 14 HOLES/206MM/RIGHT
Type of DevicePLATE, FIXATION, BONE
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
ELMIRA
35 airport road
horseheads NY
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key10112473
MDR Text Key193672115
Report Number8030965-2020-03879
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K030597
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 05/21/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/02/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.124.220
Device Lot Number18P2758
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/10/2020
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/22/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/10/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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