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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ACUMED, LLC OLECRANON PLATE, STANDARD 5-HOLE LT; PLATE, FIXATION, BONE

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ACUMED, LLC OLECRANON PLATE, STANDARD 5-HOLE LT; PLATE, FIXATION, BONE Back to Search Results
Model Number 70-0304
Device Problem Break (1069)
Patient Problem Foreign Body In Patient (2687)
Event Date 09/23/2022
Event Type  malfunction  
Manufacturer Narrative
The results of the investigation are inconclusive as the device was not received for evaluation.Manufacturing and inspection records were reviewed, and no anomalies were found.
 
Event Description
It was reported during the procedure, when the doctor was placing the olecranon plate, they used a 2.7 x 26mm non-locking hexalobe screw to fix the plate.The surgeon requested an x-ray image to observe the placement, and he realized that it was too long for the patient.The surgeon decided to remove the plate and replace with a smaller plate.Once outside the patient, the medical team realized the tip of the screw was missing.Another x-ray image was taken to confirm if the missing fragment had remained inside the patient.The procedure was completed; however, the procedure was delayed by an hour.This report is related to report number 3025141-2022-00340 which is for the screw involved in this event.
 
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Brand Name
OLECRANON PLATE, STANDARD 5-HOLE LT
Type of Device
PLATE, 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 Key15666177
MDR Text Key303246286
Report Number3025141-2022-00341
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeMX
PMA/PMN Number
K102998
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 10/21/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number70-0304
Device Catalogue Number70-0304
Device Lot Number529823
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 10/04/2022
Initial Date FDA Received10/25/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/28/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient SexFemale
Patient EthnicityHispanic
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