MAUDE Adverse Event Report: UNKNOWN IMPLANT, FIXATION DEVICE, SPINAL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abscess (1690); Unspecified Infection (1930)

Event Type  Injury  

Event Description

The patient reported they had surgery to remove the screws and rods in their back, and that they had a massive infection and abscess in their spine after the removal.The patient also reported they were in and out of the hospital 3-4 times.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: IMPLANT, FIXATION DEVICE, SPINAL
• Type of Device: IMPLANT, FIXATION DEVICE, SPINAL
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17530128
• MDR Text Key: 321075708
• Report Number: MW5137049
• Device Sequence Number: 1
• Product Code: JDN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1