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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 Failure to Osseointegrate (1863)
Patient Problem Insufficient Information (4580)
Event Type  malfunction  
Manufacturer Narrative
Additional mdrs associated with this article: 3025141-2020-00354: case 1, 3025141-2020-00355: case 2, 3025141-2020-00356: case 3, 3025141-2020-00358: case 5.
 
Event Description
Article: fibular nails for open and closed ankle fractures: results from a non-designer level i major trauma centre; al-obaidi, bilal; wiik, anatole vilhelm; bhattacharyya, rahul; mushtaq, nadeem; and bhattacharya, rajarshi; journal of orthopedic surgery 27(1) 1-6. Case 4: patient experienced non-union post op following implantation of a fibula nail. Patient was asymptomatic and treated conservatively.
 
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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 Key10999263
MDR Text Key222083540
Report Number3025141-2020-00357
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
Type of Report Initial
Report Date 11/27/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/13/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
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 Received11/27/2020
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

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