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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH 3.5MM VA-LCP PROX TIBIA PLATE SMALL BEND/4H/87MM/LEFT PLATE, FIXATION, BONE

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SYNTHES GMBH 3.5MM VA-LCP PROX TIBIA PLATE SMALL BEND/4H/87MM/LEFT PLATE, FIXATION, BONE Back to Search Results
Catalog Number 02.127.211
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/24/2022
Event Type  malfunction  
Event Description
Device report from depuy synthes reports an event in (b)(6) as follows: it was reported that on (b)(6), 2022 during an orthopedic procedure, the screws did not lock into the plate, they went through the hole. There was no surgical delay and patient impact. The surgery was completed successfully. This report is for one (1) 3. 5mm va-lcp prox tibia plate small bend/4h/87mm/left. This is report 7 of 8 for complaint (b)(4).
 
Manufacturer Narrative
Additional narrative: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. Reporter is a j&j employee. 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 Name3.5MM VA-LCP PROX TIBIA PLATE SMALL BEND/4H/87MM/LEFT
Type of DevicePLATE, FIXATION, BONE
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
WERK RARON (CH)
kanalstrasse west 30
raron 3942
SZ 3942
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key13902722
MDR Text Key288180390
Report Number8030965-2022-01907
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeCO
PMA/PMN Number
K120689
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/25/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number02.127.211
Device Lot Number444P016
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Date Manufacturer Received05/03/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured10/12/2021
Is the Device Single Use? Yes
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 03/25/2022 Patient Sequence Number: 1
Treatment
3.5 VA LCK SCRW/SLF-TP/STRD/36.; 3.5 VA LCK SCRW/SLF-TP/STRD/44.; 3.5 VA LCK SCRW/SLF-TP/STRD/46.; 3.5 VA LCK SCRW/SLF-TP/STRD/50.; 3.5 VA LCK SCRW/SLF-TP/STRD/54.; SCREW Ø3.5 SELF-TAP FULL-THR L60 T15 SST.; SCREW Ø3.5 SELF-TAP FULL-THR L65 T15 SST.
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