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U.S. Department of Health and Human Services

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

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ACUMED, LLC ACU-LOC 2 VDR PLATE PLATE, FIXATION, BONE Back to Search Results
Model Number UNKNOWN
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/17/2022
Event Type  malfunction  
Manufacturer Narrative
The results of the investigation are inconclusive as the device was not returned for evaluation. Manufacturing and inspection records could not be reviewed as device information (model number, batch/lot number) is unknown.
 
Event Description
It was reported the removal instruments failed to remove the screws from the plate and from the bone after the plate was removed. Competitor devices were needed to successfully remove the hardware. This issue resulted in the procedure taking a few hours. This report is related to report numbers: 3025141-2022-00093, 3025141-2022-00094, 3025141-2022-00095, 3025141-2022-00096, 3025141-2022-00097, 3025141-2022-00098, 3025141-2022-00099, 3025141-2022-00100, 3025141-2022-00102, and 3025141-2022-00103 for the other devices involved in this event.
 
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Brand NameACU-LOC 2 VDR 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 Key14190161
MDR Text Key289965022
Report Number3025141-2022-00101
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeUS
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 04/18/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/22/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUNKNOWN
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received03/24/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No

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