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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ACUMED, LLC OLECRANON PLATE, STANDARD 7-HOLE RT PLATE, FIXATION, BONE

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ACUMED, LLC OLECRANON PLATE, STANDARD 7-HOLE RT PLATE, FIXATION, BONE Back to Search Results
Model Number 70-0307
Device Problem Break (1069)
Patient Problem Insufficient Information (4580)
Event Date 03/06/2022
Event Type  Injury  
Event Description
It was reported the plate broke post-operatively two months after the initial implant procedure, and the plate and screws were explanted. No other information is available. This report is related to report number 3025141-2022-00206 for the screw involved in this event.
 
Manufacturer Narrative
The results of the investigation are inconclusive as the device was not returned for evaluation. Manufacturing and inspection records were reviewed and not anomalies were found.
 
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Brand NameOLECRANON PLATE, STANDARD 7-HOLE RT
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 Key14982015
MDR Text Key295678635
Report Number3025141-2022-00205
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeIS
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,Followup
Report Date 08/10/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/11/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number70-0307
Device Catalogue Number70-0307
Device Lot Number515177
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Manufacturer Received08/09/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/09/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/11/2022 Patient Sequence Number: 1
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