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

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.

• Brand Name: PROXIMAL HUMERUS PLATE, 3 HOLE LEFT
• Type of Device: PROXIMAL 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 Key: 6903777
• MDR Text Key: 87846380
• Report Number: 3009222247-2017-00018
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141493
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MDS130103L
• Device Catalogue Number: MDS130103L
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/29/2017
• Initial Date FDA Received: 09/29/2017
• 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 Sequence Number: 1
• Patient Outcome(s): Required Intervention