• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ACUMED, LLC PLATE, FIXATION, BONE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ACUMED, LLC 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 04/28/2022
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
During the procedure when inserting the locking screw of aculoc 2, the screw did not fully seat into the plate, and a piece of metal emerged from the screw. The screw was disposed of at the hospital, and device information for the plate (model number, batch/lot number) is unknown. There were no adverse consequences for the patient and no delay in procedure. This report is related to report number 3025141-2022-00161 for the screw involved in this event.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key14579249
MDR Text Key294672289
Report Number3025141-2022-00162
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeJA
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 05/26/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/02/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Date Manufacturer Received05/12/2022
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

-
-