MAUDE Adverse Event Report: SYNTHES (USA), LLC SYNTHES 6 HOLE CLUSTER CLAVICLE PLATE; PLATE, FIXATION, BONE

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Chest Pain (1776); Inflammation (1932); Metal Related Pathology (4530); Reaction to Medicinal Component of Device (4574); Swelling/ Edema (4577)

Event Date 07/01/2021

Event Type  Injury  

Event Description

Synthesis 6-hole lateral cluster clavicle plate was placed on my right clavicle (b)(6) 2021.During the following summer months i noticed a softball sized orange spot on the worn finish of my very old cast-iron bathtub where my shoulder touches when i take a bath.That spot continues to be there, it has not faded nor expanded.I believe this orange chromehidrosys from my shoulder is the result of metallosis from the plate.The serial number on the plate is (b)(4).I also experienced significant pain and inflammation in my right upper chest and arm during the time the plate was attached to my clavicle that was relieved within two days after its removal on (b)(6) 2022.I believe this was an allergic reaction to the plate.Fda safety report id # (b)(4).

• Brand Name: SYNTHES 6 HOLE CLUSTER CLAVICLE PLATE
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES (USA), LLC
• MDR Report Key: 13734632
• MDR Text Key: 287247214
• Report Number: MW5108036
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: MAGNESIUM.; MELATONIN.; POTASSIUM.; RESVERATROL.; TURMERIC.; VIT. B.; VIT. C; VIT. D; VIT. K; ZINC.
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White