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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/8H/147MM/RIGHT PLATE, FIXATION, BONE

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SYNTHES GMBH 3.5MM VA-LCP PROX TIBIA PLATE SMALL BEND/8H/147MM/RIGHT PLATE, FIXATION, BONE Back to Search Results
Catalog Number 02.127.230
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Product complaint # (b)(4). Additional product code: hwc. Complainant part is not expected to be returned for manufacturer review/investigation. Without a lot number, the device history records review could not be completed as no product was received. 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 an unknown date, when lock screw passes through the plate, the aiming arm cannot be combined. It was unknown when it was occurred. The patient outcome was unknown. This complaint involves five (5) devices. This report is for (1) 3. 5mm va-lcp prox tibia plate small bend/8h/147mm/right. This report is 1 of 5 for (b)(4).
 
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Brand Name3.5MM VA-LCP PROX TIBIA PLATE SMALL BEND/8H/147MM/RIGHT
Type of DevicePLATE, FIXATION, BONE
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
WERK HÄGENDORF (CH)
im bifang 6
haegendorf 4614
SZ 4614
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key12617679
MDR Text Key281217778
Report Number8030965-2021-08611
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeTW
PMA/PMN Number
K120689
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,Followup,Followup
Report Date 09/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/12/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number02.127.230
Device Lot Number4L90187
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/15/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/25/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/06/2019
Is the Device Single Use? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 10/12/2021 Patient Sequence Number: 1
Treatment
3.5 VA P TIB S BEND/10H/177/RT; UNK - GUIDES/SLEEVES/AIMING: AIMING ARM; UNK - PLATES: TRAUMA; VA LOCKSCR Ø3.5 SELF-TAP L60 SST
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