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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ACUMED, LLC 8 HOLE DORSOLATERAL MIDSHAFT RADIUS PLATE PLATE, FIXATION, BONE

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ACUMED, LLC 8 HOLE DORSOLATERAL MIDSHAFT RADIUS PLATE PLATE, FIXATION, BONE Back to Search Results
Model Number 70-0075
Device Problem Break (1069)
Patient Problem Non-union Bone Fracture (2369)
Event Date 03/04/2022
Event Type  Injury  
Event Description
It was reported the 8 hole dorsolateral radius plate (part number 70-0075) failed post-operatively approximately 13 weeks after the primary surgery. It was also reported post-operative office visit x-rays show the plate to be intact. ; however, subsequent office visit films showed the failure of the plate resulting in non-union. Follow up was conducted which determined the patient had reported being compliant with post-op instructions. A revision procedure was performed on (b)(6) 2022 to explant the fractured plate and explant the screws and replace with competitor product. The current status of the patient is unknown. Additionally, the batch/lot number(s) of the implanted screws, except for one screw, were unknown, and only the plate involved in this event was returned for evaluation. The event date (when plate fracture occurred) is unknown. The event date provided in this report is an estimate based on the information provided. This is 1 of 8 reports for this event and is related to report numbers 3025141-2022-00081, 3025141-2022-00082, 3025141-2022-00083, 3025141-2022-00084, 3025141-2022-00085, 3025141-2022-00086, and 3025141-2022-00087 which are for the screws involved in this event.
 
Manufacturer Narrative
Manufacturing and inspection records were reviewed, and no anomalies were found. The returned 8 hole dorsolateral midshaft radius plate was examined visually under magnification. The fracture occurred across one of the middle slots and was noted to be a fast fracture due to overload. From the x-rays provided, it appeared that this slot was over the fracture site (diagonal/transverse fracture). The x-rays showed that the failure occurred over the fracture site, resulting in a twist of the plate and bones along with it. The surgical technique recommends that the middle of the plate be positioned over the fracture site to optimize compression. Placing a slot over the fracture site decreases the stability of the plate construct as there is less material to support the fracture. No screws were returned for this incident. Based on the information provided and the investigation performed, no definitive conclusion on the cause of the incident can be made.
 
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Brand Name8 HOLE DORSOLATERAL MIDSHAFT RADIUS 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 Key14115965
MDR Text Key289494143
Report Number3025141-2022-00080
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 04/13/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/14/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number70-0075
Device Catalogue Number70-0075
Device Lot Number289148
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/28/2022
Date Manufacturer Received03/16/2022
Was Device Evaluated by Manufacturer? Yes
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 04/14/2022 Patient Sequence Number: 1
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