MAUDE Adverse Event Report: MIAMI DEVICE SOLUTIONS PROXIMAL HUMERUS PLATE, 5 HOLE, RIGHT

Model Number MDS130105R

Device Problems Loosening of Implant Not Related to Bone-Ingrowth (4002); Migration (4003)

Patient Problem Non-union Bone Fracture (2369)

Event Date 06/22/2021

Event Type  Injury  

Manufacturer Narrative

On july 8 2021, the university of (b)(6) medicine ((b)(6)) contacted (b)(4) regarding the removal surgery, and provided (b)(4) with a copy of form fda 3500.However, upon review of form fda 3500, completed by (b)(6), the "brand name", "common device name", "model #", "lot number were incorrect.The information provided by the hospital, via e-mail, stated: "miami device solutions proximal humerus plates"- "the implant failed in a very unusual fashion with the plate pulling off the bone through the screws with the screw heads remaining intact".

Event Description

This event was the second revision surgery, in which the plating system was explanted on (b)(6) 2021.The x-rays provided demonstrate the two most distal screws of the plate pushed through the plate.The third most distal screw of the plate had loosened from the bone as it had migrated away from the plate, and the screws on the proximal humerus head were intact.The surgeon was able to remove the screws, plate, and locking caps without any issues.No delays or patient impact were reported.

• Brand Name: PROXIMAL HUMERUS PLATE, 5 HOLE, RIGHT
• Type of Device: PROXIMAL HUMERUS PLATE, 5 HOLE, RIGHT
• Manufacturer (Section D): MIAMI DEVICE SOLUTIONS; 7620 nw 25 st; suite 3 & 4 FL 33122
• Manufacturer (Section G): BIEDERMANN MOTECH, INC.; 7620 nw 25 st; suite 3 & 4; miami FL 33122
• Manufacturer Contact: joselito hernandez ; 7620 nw 25 st; suite 3 & 4; miami, FL 33122 ; 3057225310
• MDR Report Key: 12228260
• MDR Text Key: 263581801
• Report Number: 3009222247-2021-00008
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 108122690200104
• UDI-Public: (01)108122690200104(10)BDKF8SL
• 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: distributor
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 07/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MDS130105R
• Device Catalogue Number: MDS130105R
• Device Lot Number: BDKF8SL
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/30/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2016
• 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
• Treatment: SCREWS, LOCKING CAPS
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR