MAUDE Adverse Event Report: MEDTRONIC MEDICAL COSTA RICA S.R.L. GDLH® POSTERIOR SPINAL SYSTEM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Model Number	855-011
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Back pain (4895)
Date of Event	11/15/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received from healthcare provider (hcp) via a manufacturer representative regarding a patient having spinal therapy.It was reported that following physical labor in the garden, the patient bent down and experienced a crunch and pain in the back.Subsequent findings included a paravertebral calculus abscess and an epidural calculus abscess.Interventions performed included thoracotomy on the left, drainage of the paravertebral calculus abscess, resection of th10-th12 vertebral bodies, removal of the epidural calculus abscess, and combined interbody fusion (corporodesis) from th1 to l1 using mesh, auto-rib, and allocity.The patient had a symptom of back pain.There were no complications reported as a result of this event.Additional information received that the rod fracture happened and there was a plan for revision surgery at the end of(b)(6) 2026.Additional information received that the revision surgery had happened on (b)(6) 2026.
Additional Manufacturer Narrative
H6: neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: GDLH® POSTERIOR SPINAL SYSTEM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): MEDTRONIC MEDICAL COSTA RICA S.R.L.; coyol free zone building b7; multi-tenant 7-8; coyol 20113 ; CS 20113
• Manufacturer (Section G): MEDTRONIC MEDICAL COSTA RICA S.R.L.; coyol free zone building b7; multi-tenant 7-8; coyol 20113 ; CS 20113
• Manufacturer Contact: justin ellis ; 1800 pyramid place; memphis, TN 38132 ; 7635265677
• MDR Report Key: 24510534
• Report Number: 3014725904-2026-00033
• Device Sequence Number: 18752062
• Product Code: KWP
• UDI-Device Identifier: 00673978061825
• UDI-Public: (01)00673978061825(11)140722(10)0319078W
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: K954645
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/04/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 855-011
• Device Catalogue Number: 855-011
• Device Lot Number: 0319078W
• 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: 02/15/2026
• Initial Report FDA Received Date: 03/04/2026
• Date Device Manufactured: 07/22/2014
• 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: Required Intervention
• Patient Age: 45 YR
• Patient Sex: Male