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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH LCP DHS-PL 135° 3HO L76 STANDBARREL TAN ROD, FIXATION, INTRAMEDULLARY

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OBERDORF SYNTHES PRODUKTIONS GMBH LCP DHS-PL 135° 3HO L76 STANDBARREL TAN ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Catalog Number 04.224.223S
Device Problem Device Handling Problem (3265)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/29/2019
Event Type  malfunction  
Manufacturer Narrative
Expiration date is unknown. Complainant part is not expected to be returned for manufacturer review/ investigation. Device is not distributed in the united states, but is similar to device marketed in the usa. 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 on (b)(6) 2019, the patient underwent open reduction internal fixation surgery for femoral trochanteric fracture with the lcp dhs plate in question. During the surgery, the surgeon inserted the blade (length 70mm). The surgeon originally had to use a plate with shorter barrel, but she used the plate with the standard barrel. The plate was fixed, but the distance between the blade part and the barrel part was shorter than usual, because the surgeon used the standard barrel plate. The fracture was atypical, and there was a gap (about 1-2mm long) around the femur calcar. The surgeon commented that the cut-out will not occur because the plate will hardly slide. There was no surgical delay. No further information is available. This complaint involves two (2) devices. This report is for one (1) lcp dhs-pl 135° 3ho l76 standbarrel tan. This report is 1 of 2 for (b)(4).
 
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Brand NameLCP DHS-PL 135° 3HO L76 STANDBARREL TAN
Type of DeviceROD, FIXATION, INTRAMEDULLARY
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
SYNTHES SELZACH
bohackerweg 5
selzach 2545
SZ 2545
Manufacturer Contact
kara ditty-bovard
eimattstrasse 3
oberdorf 4436
SZ   4436
6103142063
MDR Report Key9120772
MDR Text Key191977994
Report Number8030965-2019-68707
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeJA
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 08/29/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/25/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.224.223S
Device Lot Number3L91202
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 Received10/02/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/22/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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