MAUDE Adverse Event Report: MIAMI DEVICE SOLUTIONS BROAD PLATE, 3.5T; BROAD PLATE, 3.5T, 14 HOLES

Model Number MDS1101B14

Device Problems Break (1069); Fracture (1260)

Patient Problem Limb Fracture (4518)

Event Date 01/05/2021

Event Type  Injury  

Event Description

The subject plate was implanted, in a peri-prosthetic humeral repair, at or around (b)(6) 2020.The peri-prosthetic repair was to implant a mds1101b14 plate over a fracture caused by a fall at the distal end of the prosthetic stem.The patient was "doing fine" as reported by the revision surgery surgeon.At or around three (3) weeks prior to the subject revision surgery the patient fell in the shower without any indications of trauma to the bone or plate, as reported by the patient.A week prior to the subject revision surgery the patient woke up with pain and unable to move her arm.The subject revision surgery was to remove the broken plate.

• Brand Name: BROAD PLATE, 3.5T
• Type of Device: BROAD PLATE, 3.5T, 14 HOLES
• Manufacturer (Section D): MIAMI DEVICE SOLUTIONS; 7620 nw 25 st suite 3 & 4; miami FL 33122
• Manufacturer (Section G): BIEDERMANN MOTECH, INC.; 7620 nw 25 st unit 3 & 4; miami FL 33122
• Manufacturer Contact: joselito hernandez ; 7620 nw 25 st unit 3 & 4; miami, FL 33122 ; 3057225310
• MDR Report Key: 11250854
• MDR Text Key: 229346387
• Report Number: 3009222247-2021-00001
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 10812269024362
• UDI-Public: (01)10812269024362(10)18003563
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172786
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 01/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MDS1101B14
• Device Catalogue Number: MDS1101B14
• Device Lot Number: 18003563
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2021
• Date Manufacturer Received: 01/01/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/24/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention