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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ACUMED LLC ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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ACUMED LLC ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Device Problem Therapeutic or Diagnostic Output Failure (3023)
Patient Problem Bone Fracture(s) (1870)
Event Type  Injury  
Manufacturer Narrative
Additional mdrs associated with this article: 3025141-2020-00347: case 1, 3025141-2020-00349: case 3, 3025141-2020-00350: case 4.
 
Event Description
Article: safety and efficacy of surgical fixation of fibula fractures using an intramedullary nail: a retrospective observational cohort study in 30 patients; boni, guilherme; sanchez, gustavo t. ; arliani, gustavo; zellle, boris a. ; pires, robinson e; and dos reis, fernando b; patient safety in surgery (2019) 13:31. Case 2: patient experienced a new fracture in the area of the original fracture post op following implantation of a fibula nail. The nail was explanted and the fracture treatment was changed to a plate construct.
 
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Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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
micki anderson
5885 ne cornelius pass road
hillsboro, OR 97124
8886279957
MDR Report Key10982734
MDR Text Key220642122
Report Number3025141-2020-00348
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 11/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/10/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/20/2020
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

Patient Treatment Data
Date Received: 12/10/2020 Patient Sequence Number: 1
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