MAUDE Adverse Event Report: WARSAW ORTHOPEDIC, INC. UNKNOWN; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Model Number	1604200500
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/22/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
G2: country of origin is sweden d1, d2, d4: product identifiers are unknown g4: product identifiers are not known, hence 510k# is unknown.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.
Event or Problem Description
Information was received from healthcare provider (hcp) via a manufacturer representative regarding a patient having fusion spinal t herapy.It was reported that the tulip from the mas-screw had come loose from the screw and the rods in the construction were broken.The broken tulip was on left l4 and the rod on the left side was broken on two spots while the rod on the right side was broken in one position.There was pain in the area of the back where the broken screw was located near l4.There were no further complications reported regarding the event.Additional information received from manufacturer representative that the rod belongs to mdt.
Additional Manufacturer Narrative
D4: updated 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.
Additional Manufacturer Narrative
H3: product analysis # (b)(4): part # 1604200500; lot # 0604500w visual examination confirmed the rod has broken in multiple places.Microscopic examination of the fracture surface revealed progressive striations consistent with cyclic fatigue.No pre-existing surface defects were identified that could contribute to the rod breaking.Dimensional examination confirms conformance to print specification.After visual, microscopic and dimensional examination, no evidence was found that would suggest a defect in manufacturing or processing of the implants.The damage to the implant is consistent with cyclic fatigue followed by overload once the fatigue had weakened the rod.Gch item # 30 feature or dimension rod diameter 6.0 +/-0.05 specification location 1604200500 rev.C loc.D7-8 measurement method micrometer id# (b)(4) inspector & date ad 05 feb 2026 measurement results 6.005 mm.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: UNKNOWN
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): WARSAW ORTHOPEDIC, INC.; 2500 silveus crossing; warsaw,in TN 46582
• Manufacturer (Section G): WARSAW ORTHOPEDIC, INC.; 2500 silveus crossing; warsaw,in TN 46582
• Manufacturer Contact: justin ellis ; 1800 pyramid place; memphis, TN 38132 ; 7635265677
• MDR Report Key: 23584762
• Report Number: 3003120897-2025-00589
• Device Sequence Number: 18517915
• Product Code: KWP
• UDI-Device Identifier: 00613994990693
• UDI-Public: (01)00613994990693(11)171208(10)0604500W
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: UNKNOWN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/25/2026

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: 1604200500
• Device Catalogue Number: 1604200500
• Device Lot Number: 0604500W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2025
• Supplement Date Received by Manufacturer: 12/02/2025; 02/05/2026
• Initial Report FDA Received Date: 11/18/2025
• Supplement Report FDA Received Date: 12/30/2025; 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/08/2017
• 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: 79 YR
• Patient Sex: Unknown
• Patient Weight: 68 KG