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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MIAMI DEVICE SOLUTIONS LLC PROXIMAL HUMERUS PLATE, 3 HOLE LEFT

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MIAMI DEVICE SOLUTIONS LLC PROXIMAL HUMERUS PLATE, 3 HOLE LEFT Back to Search Results
Model Number MDS130103L
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Missing Value Reason (3192)
Event Date 08/30/2017
Event Type  Injury  
Manufacturer Narrative

Additional information per section: age and weight are unknown despite attempts to obtain this information. (b)(4). Original implantation surgery date is unknown. Investigation: the actual device associated with this mdr was not returned, therefore the device could not be inspected and the lot number is not available for a review of the dhr. An overall review of the dhr and ncr files for the product subject of this complaint was conducted. There were no findings that could have contributed to this mdr. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

 
Event Description

It has been reported that revision surgery was conducted for a miami device solutions (mds) proximal humerus plate due to nonunion.

 
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Brand NamePROXIMAL HUMERUS PLATE, 3 HOLE LEFT
Type of DevicePROXIMAL HUMERUS PLATE
Manufacturer (Section D)
MIAMI DEVICE SOLUTIONS LLC
7620 nw 25th st ste 3
miami 33122
Manufacturer Contact
anderson giraldo
7620 nw 25th st
unit 3
miami 33122
MDR Report Key6903777
MDR Text Key87846380
Report Number3009222247-2017-00018
Device Sequence Number1
Product Code HRS
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK141493
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial
Report Date 08/29/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/29/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberMDS130103L
Device Catalogue NumberMDS130103L
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/29/2017
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: 09/29/2017 Patient Sequence Number: 1
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