MAUDE Adverse Event Report: SCREW; SCREW, FIXATION, BONE

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Failure of Implant (1924); Impaired Healing (2378); Swelling/ Edema (4577)

Event Date 09/11/2020

Event Type  malfunction  

Event Description

On (b)(6) 2020 left tibia/fibula fracture repair; required orif with plate, screws, and washer; pt continues to suffer with pain, swelling, superficial wounds as of this date.Concern for implant(s) rejection reaction.Pt having implants removed due to ongoing issues.Fda safety report id# (b)(4).

• Brand Name: SCREW
• Type of Device: SCREW, FIXATION, BONE
• MDR Report Key: 11619047
• MDR Text Key: 244299100
• Report Number: MW5100574
• Device Sequence Number: 4
• Product Code: HWC
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/02/2021
• 6 Devices were Involved in the Event: 1 2 3 4 5 6

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 15 YR
• Patient Weight: 65