MAUDE Adverse Event Report: MSD DEGGENDORF MFG CAPSTONE PTC¿ SPINAL SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT,

Model Number	3992210
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Intervertebral Disc Compression or Protrusion (4524); Back pain (4895)
Date of Event	01/20/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B2: other - end plate fracture.H3: 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.
Event or Problem Description
It was reported that subject presented to primary care physician with complaint of heightened low back pain with activity and the pain was rated at 8/10 all the time.Interventions: ae resulted in drug therapy.Diagnostics: x-ray done on (b)(6) 2025 resulted in anterolisthesis of l4 on l5 measuring 1.6cm; superior endplate irregularities disc height loss at l4-l5 could represent end plate fracture due to spacer subsidence and severity of ae is severe.Sponsor assessment: sponsor assessed as possible related to tlif procedure, tlif grafting material, inter body fusion device, and po sterior supplemental fixation system.Primary diagnosis: recurrent disc herniation.Long description: back pain, anterolisthesis of l4 on l5 shown on x-ray (b)(6) 2025.Diagnostics: ct without contrast2 was done on (b)(6) 2025 which resulted in peri screw lucencies around b/l l5 screws with associated bony fragmentation/subacute appearing fractures; subsidence of disc spacer in vertebral body endplates w/ depression of the superior endplate l5.Comments: subject discussed pain management plan with pcp, continue taking post-operative pain medications including gabapentin, tramadol and tizanidine.Site related assessment: causal relationship to capstone peek spinal system implant, not related to posterior supplemental fixation system, unlikely related to tlif grafting material, and tlif procedure.
Additional Manufacturer Narrative
H6: annex e code 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
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
Sponsor assessment: cec adjudicated as causal related to tlif procedure, and possible to tlif grafting material, inter body fusion device, and posterior supplemental fixation system.
Event or Problem Description
Additional information was received: interventions: on (b)(6) 2025, a denervation procedure was performed using radiofrequency ablation (rfa).The result of the procedure was successful.On (b)(6) 2025 the patient underwent lumbar and parasacral trigger point injections under fluoroscopic guidance.The exact levels were unknown.On (b)(6) 2025 the patient underwent diagnostic medial branch facet nerve blocks at the bilateral l5-s1 facet joints under fluoroscopic guidance.On (b)(6) 2025 the patient underwent diagnostic medial branch facet nerve blocks at the bilateral l5-s1 facet joints under fluoroscopic guidance.Outcome status: recovering/resolving.Comments: trigger point injections on (b)(6) 2025 did not provide long-term pain relief.The patient subsequently underwent diagnostic medial branch blocks at the bilateral l5-s1 facet joints on (b)(6) 2025.Finally, a radiofrequency neurotomy (radiofrequency ablation of the medial branch facet nerves) at the bilateral l5-s1 facet joints was performed on (b)(6) 2025.
Additional Manufacturer Narrative
B5: additional information was received.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: CAPSTONE PTC¿ SPINAL SYSTEM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT,
• 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: 21569924
• Report Number: 1030489-2025-01280
• Device Sequence Number: 12923408
• Product Code: MAX
• UDI-Device Identifier: 00643169187535
• UDI-Public: 00643169187535
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K172199
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/15/2025

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 Model Number: 3992210
• Device Catalogue Number: 3992210
• Device Lot Number: M31334586
• 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: 02/14/2025
• Supplement Date Received by Manufacturer: 03/11/2025; 04/11/2025; 09/19/2025
• Initial Report FDA Received Date: 03/11/2025
• Supplement Report FDA Received Date: 03/11/2025; 04/15/2025; 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Age: 69 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White