MAUDE Adverse Event Report: SYNTHES LLC SCREWS; SCREW, FIXATION, BONE

Device Problem Nonstandard Device (1420)

Patient Problems Pain (1994); Scarring (2061); Swelling (2091); Ulcer (2274); Test Result (2695)

Event Type  No Answer Provided  

Event Description

My name is (b)(6).Back in (b)(6) 2009, i was in an abusive relationship.I happen to get push and he broke my arm, humerus bone.I received surgery (b)(6) 2009, a plate and screws in my arm.I got pregnant in (b)(6) 2013.All of a sudden, (b)(6) 2014, i notice a knot on my pregnancy visit.They mention it was probably my hormones.Summer of 2015 right before my vacation that area swelled up like the size of a small golf ball.Went to (b)(6) dermatologist and they diagnosed that i had pyodermia gangrenosum.Drain the pus, sent it to lab.I was put on doxycycline."went back for steroid shot, cut out died tissue, and it happen fluid up for a while".Pus "linking" out, so between 2015 and 2019.I've gone to (b)(6) dermatology, (b)(6) plastic surgery, and (b)(6).Went to (b)(6) plastic surgery, for a misdiagnoses from (b)(6) dermatology who said it was a keloid, when it was back filled with pus.Drained it a gain, sent to lab.(b)(6) dermatology sent me there for an xrt.They were wrong.I finally went (b)(6) dr did x-rays.They were fine, he mention it was probably bacteria in the screws.I work with the public, so one of my customers work for the hosp and mentioned recall on screws and plates.So i got my papers as to what screws are in my arm.I research and (b)(6) and found the recall.This has been going on from 2014 - 2019.I have bills from dr's office to be reimburse to me, lab bills, x-ray bills, pain and suffering.My arm is embarrassing, i keep it covered up, painful, and it's an ugly scar.This has to come out, pain and suffering and reimbursement, dr visits, labs and x-rays.I need help, and a lawyer.I've been getting the run around.Plate is still in right arm.Thank you, (b)(6).

• Brand Name: SCREWS
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): SYNTHES LLC
• MDR Report Key: 9711502
• MDR Text Key: 180126047
• Report Number: MW5093007
• Device Sequence Number: 2
• Product Code: HWC
• 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: 02/02/2020
• 5 Devices were Involved in the Event: 1 2 3 4 5

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 42 YR
• Patient Weight: 68