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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ACUMED LLC; SCREW, FIXATION, BONE
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ACUMED LLC; SCREW, FIXATION, BONE Back to Search Results
Device Problems Break (1069); Appropriate Term/Code Not Available (3191)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  Injury  
Manufacturer Narrative
Additional mdrs associated with this event: 3025141-2020-00155: plate, 3025141-2020-00170: screw 1, 3025141-2020-00171: screw 2, 3025141-2020-00172: screw 3, 3025141-2020-00173: screw 4, 3025141-2020-00174: screw 5, 3025141-2020-00175: screw 6, 3025141-2020-00176: screw 7, 3025141-2020-00177: screw 8, 3025141-2020-00178: screw 9.
 
Event Description
An olecranon plate was implanted in the patient on (b)(6) 2019.The plate broke at some point post op and was removed in a revision surgery on (b)(6) 2019.
 
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Type of Device
SCREW, FIXATION, BONE
Manufacturer (Section D)
ACUMED LLC
5885 ne cornelius pass road
hillsboro, or
Manufacturer (Section G)
ACUMED LLC
5885 ne cornelius pass road
hillsboro, or
Manufacturer Contact
micki anderson
5885 ne cornelius pass road
hillsboro, or 
6279957138
MDR Report Key10270958
MDR Text Key198755540
Report Number3025141-2020-00179
Device Sequence Number1
Product Code HWC
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 07/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/14/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Date Manufacturer Received07/06/2020
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 Sequence Number1
Patient Outcome(s) Required Intervention;
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