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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH VA-LCP DHP 2.7/3.5 DORSO-LAT W/SUPP-LAT PLATE, FIXATION, BONE

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SYNTHES GMBH VA-LCP DHP 2.7/3.5 DORSO-LAT W/SUPP-LAT PLATE, FIXATION, BONE Back to Search Results
Catalog Number 04.117.103S
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/29/2022
Event Type  malfunction  
Event Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6), 2022, the patient underwent the osteosynthesis surgery for distal humerus fracture with the plate in question. In the surgery, the locking mechanism of the plate hole did not work normally in the most distal right hole of the plate. Therefore, the plate was replaced with a new one. The surgery was completed successfully with 60 minutes delay. No further information is available. This report is for one (1) va-lcp dhp 2. 7/3. 5 dorso-lat w/supp-lat. This is report 1 of 1 for complaint product complaint (b)(4).
 
Manufacturer Narrative
Reporter is a j&j employee. Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. 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.
 
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Brand NameVA-LCP DHP 2.7/3.5 DORSO-LAT W/SUPP-LAT
Type of DevicePLATE, FIXATION, BONE
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
SYNTHES SELZACH
bohackerweg 5
selzach 2545
SZ 2545
Manufacturer Contact
kate karberg
1302 wright lane east
west chester, PA 19380
3035526892
MDR Report Key14208715
MDR Text Key290542899
Report Number8030965-2022-02689
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K120717
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/26/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/26/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.117.103S
Device Lot Number506P421
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/29/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes

Patient Treatment Data
Date Received: 04/26/2022 Patient Sequence Number: 1
Treatment
UNK - SCREWS: LOCKING
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