MAUDE Adverse Event Report: MSD DEGGENDORF MFG CD HORIZON® SPINAL SYSTEM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Model Number	75445540
Medical Device Problem Codes	Corroded (1131); Biocompatibility (2886); Material Twisted/Bent (2981)
Health Effect - Clinical Codes	Arrhythmia (1721); Autoimmune Disorder (1732); Cerebrospinal Fluid Leakage (1772); Foreign Body Reaction (1868); Inflammation (1932); Neuropathy (1983); Rash (2033); Anxiety (2328); Swollen Lymph Nodes/Glands (4432); Metal Related Pathology (4530); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
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.Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: 75446550, serial/lot #: unknown, ubd: 30-sep-2011, udi# (b)(4); 510(k) no:k042025; product id: 75446540, serial/lot #: unknown, ubd: 30-sep-2011, udi# (b)(4); 510(k) no:k042025; product id: 869-021, serial/lot #: unknown, ubd: 30-sep-2011, udi# (b)(4) ;510(k) no:k040962; product id: 7540020, serial/lot #: unknown, ubd: 30-sep-2011, udi# (b)(4) ;510(k) no:k052187; product id: 8115545, serial/lot #: unknown, ubd: 30-sep-2011, udi#(b)(4) ; 510(k) no:k030840.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 received from consumer, manufacturer representative regarding an event happened during post-op of the reported implants.It was reported that, patient was allergic to nickel and experiencing symptoms.Revision surgery was planned.No further complications reported.Procedure/technique performed was transforaminal lumbar interbody fusion (tlif) at the levels l1-l3.Initial surgery was performed in the (b)(6) 2007.No further complications reported patient appeared for existing l2 fracture, status post l1-l3 fusion with instrumentation, presented for revision surgery.The revision surgery was performed for re-exploration of the l2 fracture, t12-l3 fusion extension, repair of tongue laceration, revision of the instrumentation due to hardware loosening.The products were explanted during revision surgery and sent to lab for forensic analysis, it was discovered that there was corrosion and bending of rods.It was stated that, in 2022 patient developed metallosis and adverse local tissue reactions (altr) through heavy metal urine tests and mri imaging.Patient had serious soft tissue issues throughout his body and last week it was told that he will need all the teeth removed to damage attributed to heavy metal poisoning and have severe periodontal disease along with temporo-mandibular joint.
Additional Manufacturer Narrative
Correction: b1.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
Additional information: b5, d6b, d10, h6, additional codes.Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: 75446550, serial/lot #: unknown, ubd: 30-sep-2011, udi# (b)(4); 510(k) no:k042025; product id: 75446540, serial/lot #: unknown, ubd: 30-sep-2011, udi# (b)(4) ;510(k) no:k042025; product id: 869-021, serial/lot #: unknown, ubd: 30-sep-2011, udi# (b)(4); 510(k) no:k040962; product id: 7540020, serial/lot #: unknown, ubd: 30-sep-2011, udi# (b)(4);510(k) no:k052187; product id: 8115545, serial/lot #: unknown, ubd: 30-sep-2011, udi# (b)(4); 510(k) no:k030840 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
Additional information received stating the implants were removed in 2023.Patient noted skin issues and pain, and he was told nickel was present.It was mentioned that infuse supposed to be used within 14 days within fracture, but it was used on him around 30 days.The hardware implants were corroded and released metal into body and had an allergy.Patient had tumors in brain, kidneys, lupus, multiple sclerosis, edema, chronic pancreatitis, heart palpations, anxiety, neuropathy, colitis, skin rashes, all teeth removed due to heavy metal poisoning, lymphatic system issues.Screws in spine were leaking cerebro-spinal fluid, etc., rods were bent, and then corrosion was found.The reported products were explanted and most of the symptoms were resolved apart from soft tissue problem and connective tissue.No further complications reported.

• Brand Name: CD HORIZON® SPINAL SYSTEM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): MSD DEGGENDORF MFG; wertstrasse 17; deggendorf 94469 ; GM 94469
• Manufacturer (Section G): MSD DEGGENDORF MFG; wertstrasse 17; deggendorf 94469 ; GM 94469
• Manufacturer Contact: justin ellis ; 1800 pyramid place; memphis, TN 38132 ; 7635265677
• MDR Report Key: 20307594
• Report Number: 1030489-2024-01198
• Device Sequence Number: 8712340
• Product Code: KWP
• UDI-Device Identifier: 00885074134017
• UDI-Public: 00885074134017
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K042025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/24/2025

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 Expiration Date: 09/30/2011
• Device Model Number: 75445540
• Device Catalogue Number: 75445540
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/21/2022
• Supplement Date Received by Manufacturer: 09/02/2025; 09/02/2025
• Initial Report FDA Received Date: 09/26/2024
• Supplement Report FDA Received Date: 09/24/2025; 09/24/2025
• Date Device Manufactured: 10/18/2006
• 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
• Concomitant Medical Products and Therapy/Usage Dates: "SEE H11."; SEE H11.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 84 KG