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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 3.5MM LCP MEDIAL PROXIMAL TIBIA PLATE 8H/RIGHT 145MM PLATE, FIXATION, BONE

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OBERDORF SYNTHES PRODUKTIONS GMBH 3.5MM LCP MEDIAL PROXIMAL TIBIA PLATE 8H/RIGHT 145MM PLATE, FIXATION, BONE Back to Search Results
Catalog Number 239.958
Device Problem Use of Device Problem (1670)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/13/2020
Event Type  malfunction  
Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation. Reporter is a j&j employee. A device history record (dhr) review was conducted: part number: 239. 958, lot number: 57p7002, part manufacture date: 02-jun-2020, manufacturing location: (b)(4), part expiration date: n/a, nonconformance noted: n/a. Dhr record review: a review of the device history record revealed no complaint related anomalies. The device history record shows this lot of lcp med prox-tibpl 3. 5 r shaft 8ho l145 product was processed through the normal manufacturing and inspection operations with no rework nor nonconformities noted. This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition. A review of the raw material device history record revealed this lot met all specifications with no nonconformance noted. This raw material lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition. 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 the during a right femur osteosynthesis procedure performed on (b)(6) 2020, while fixing the lateral part of the femur with a condylar support plate, the surgeon stated that he must also fix the femur medially and decides to use a 3. 5 proximal right medial tibial plate since at that time there was no other option available. The procedure was successfully completed. No further information provided. This report is for one (1) 3. 5mm lcp medial proximal tibia plate 8h/right 145mm. This is report 1 of 1 for complaint (b)(4).
 
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Brand Name3.5MM LCP MEDIAL PROXIMAL TIBIA PLATE 8H/RIGHT 145MM
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 14845
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key10804583
MDR Text Key215350551
Report Number8030965-2020-08735
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeCO
PMA/PMN Number
K050646
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 10/13/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/06/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number239.958
Device Lot Number57P7002
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/09/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/02/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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