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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ACUMED LLC ACU-LOC® 2 VDR PLT STD L PLATE, FIXATION, BONE

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ACUMED LLC ACU-LOC® 2 VDR PLT STD L PLATE, FIXATION, BONE Back to Search Results
Model Number 70-0356
Device Problems Break (1069); Device Damaged by Another Device (2915)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 03/17/2020
Event Type  malfunction  
Manufacturer Narrative
Additional mdrs associated with this event: 3025141-2020-00061: driver, 3025141-2020-00063: screw.
 
Event Description
While inserting a screw into a orthopedic plate, the driver broke off the screw head and could not be removed. It remains implanted.
 
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Brand NameACU-LOC® 2 VDR PLT STD L
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
micki anderson
5885 ne cornelius pass road
hillsboro, OR 97124
MDR Report Key9899352
MDR Text Key186746124
Report Number3025141-2020-00062
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 distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 03/17/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/30/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number70-0356
Device Catalogue Number70-0356
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/17/2020
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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