MAUDE Adverse Event Report: RHYTHMLINK INTERNATIONAL, LLC RLSND131-2.5; SUBDERMAL NEEDLE ELECTRODE

Model Number	RLSND131-2.5
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/28/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
During a transforaminal interbody fusion the device was used as an ulnar stimulating electrode at the wrist.Upon removal, the needle broke and a piece of the needle remained in the patient requiring a small incision to remove.The part number was identified as (b)(4), lot number pm00024421.

• Brand Name: RLSND131-2.5
• Common Device Name: SUBDERMAL NEEDLE ELECTRODE
• Manufacturer (Section D): RHYTHMLINK INTERNATIONAL, LLC; 1140 first street south; columbia SC 29209
• Manufacturer Contact: sandra o'reilly ; 1140 first street south; columbia, SC 29209 ; 6783341720
• MDR Report Key: 16619859
• Report Number: 1067162-2023-00001
• Device Sequence Number: 17973156
• Product Code: GXZ
• UDI-Device Identifier: 10816312020202
• UDI-Public: (01)10816312020202
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/04/2024
• Device Model Number: RLSND131-2.5
• Device Catalogue Number: RLSND131-2.5
• Device Lot Number: PM00024421
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2023
• Initial Report FDA Received Date: 03/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/05/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown