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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ACUMED, LLC ACU-LOC® 2 VDR PROX PLT, NARROW, R PLATE, FIXATION, BONE

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ACUMED, LLC ACU-LOC® 2 VDR PROX PLT, NARROW, R PLATE, FIXATION, BONE Back to Search Results
Model Number 70-0353
Device Problem Material Fragmentation (1261)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/21/2022
Event Type  malfunction  
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Brand NameACU-LOC® 2 VDR PROX PLT, NARROW, R
Type of DevicePLATE, FIXATION, BONE
Manufacturer (Section D)
ACUMED, LLC
5885 ne cornelius pass road
hillsboro OR 97124
Manufacturer (Section G)
ACUMED LLC
5885 ne cornelius pass road
hillsboro OR 97124
Manufacturer Contact
ellie wood
5885 ne cornelius pass road
hillsboro, OR 97124
5035209618
MDR Report Key15070816
Report Number3025141-2022-00228
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K102998
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 07/18/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/20/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number70-0353
Device Catalogue Number70-0353
Was Device Available for Evaluation? No
Date Manufacturer Received06/22/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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