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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ACUMEDLLC; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT: NAIL
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ACUMEDLLC; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT: NAIL Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Disc Impingement (2655)
Event Type  Injury  
Manufacturer Narrative
Additional mdrs associated with this article: 3025141-2019-00514: case 1, 3025141-2019-00515: case 2, 3025141-2019-00516: case 3, 3025141-2019-00517: case 4, 3025141-2019-00518: case 5, 3025141-2019-00519: case 6, 3025141-2019-00520: case 7, 3025141-2019-00521: case 8, 3025141-2019-00522: case 9, 3025141-2019-00523: case 10, 3025141-2019-00524: case 11, 3025141-2019-00525: case 12, 3025141-2019-00526: case 13, 3025141-2019-00528: case 15, 3025141-2019-00529: case 16, 3025141-2019-00530: case 17, 3025141-2019-00531: case 18.
 
Event Description
Article: polarus nail fixation for proximal humeral fractures, fazal, ma; baloch, irshad; ashwood, n.; journal of orthopaedic surgery 2014: 22(2):195-8.Case 14: patient experienced impingement symptoms following implantation of a polarus nail; removed distal anteroposterior screw.
 
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Type of Device
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT: NAIL
Manufacturer (Section D)
ACUMEDLLC
5885 ne cornelius pass road
hillsboro OR 97124
Manufacturer (Section G)
ACUMEDLLC
5885 ne cornelius pass road
hillsboro OR 97124
Manufacturer Contact
micki anderson
5885 ne cornelius pass road
hillsboro, OR 97124
8886279957
MDR Report Key9290426
MDR Text Key167410918
Report Number3025141-2019-00527
Device Sequence Number1
Product Code LXH
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 10/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/07/2019
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 Received10/25/2019
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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