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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ACUMED, LLC ACU-LOC 2 PLATE PLATE, FIXATION, BONE

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ACUMED, LLC ACU-LOC 2 PLATE PLATE, FIXATION, BONE Back to Search Results
Device Problems Material Fragmentation (1261); Device-Device Incompatibility (2919)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/10/2022
Event Type  malfunction  
Manufacturer Narrative
The results of the investigation are inconclusive as the plate was not returned for evaluation. Manufacturing and inspection records could not be reviewed as device information (model number and batch/lot number) is unknown.
 
Event Description
It was reported that during the procedure when inserting the locking screw of aculoc 2 (plate information is unknown), the screw didn't fully seat into the plate. A piece of metal emerged from the screw. The screw was disposed of at the hospital. This report is related to report number 3025141-2022-00124 which is for the screw involved in this event.
 
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Brand NameACU-LOC 2 PLATE
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 Key14286599
MDR Text Key290801150
Report Number3025141-2022-00125
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K120903
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 04/27/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/05/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Date Manufacturer Received04/12/2022
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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