MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG CD HORIZON® SPINAL SYSTEM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Model Number	7576545
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Pain (1994); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from healthcare provider (hcp) via a manufacturer representative regarding an event which occurred post a l5 mis tlif procedure.It was reported that the screw broke and it was explanted. there was no patient symptom reported.There were no further complications reported regarding the event.
Event or Problem Description
During the revision procedure, the post-op dislodged screw with size 6.5x45mm was removed and replaced with a larger screw (size 7.5x50mm sextant screw).Additionally, another capstone cage with size 10x22mm capstone was placed successfully to convert the tlif with 10x22mm capstone to plif.However, while using the sextant reduction instruments at the left l5 pedicle screw to reduce the listhesis, doctor felt the instrument tightening suddenly gone loose.Upon inspection, he found out that the head of the screw was still in the instrument, while the screw shaft was intact in the vertebral body same size as the first dislodge screw 6.5x45mm sextant screw, doctor replaced the 2nd dislodge screw with a larger 7.5x50mm sextant screw.
Additional Manufacturer Narrative
B5: event details updated, g2: complaint source updated.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.
Additional Manufacturer Narrative
Product analysis: part # 7576545, lot # h5809045 visual inspection confirmed the legacy screw was returned with the bone screw shank separated from the pedicle head.Macroscopic inspection revealed the multi axial ring has been damaged also due to the bone screw shank pulling loose.The separation appears to be from overload as the root cause due to the shift anteriorly which put more strain on the l5 screws.The internal testing shows a load of 3100n -5400n (tr12-249) depending on lmc/mmc to separate the head assembly from the shank.H6: fdm and fdr codes 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
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.
Event or Problem Description
On (b)(6) 2023: pre-operative diagnosis: spondylolytic spondylolisthesis l5-s1 procedure technique: patient placed under ga.Lntraop neuromonitoring devices placed.Patient placed prone on spine table.Ortho prep and drapes.Perc pin inserted on right lilac.O-arm and stealth station navigation system set up.Guide wires inserted on both pedicle of l5 and s1.Tube retractors inserted around left ls-s1 facet joint.Facetectomy done.Dura and nerve root retracted medially discectomy and endplate preparation of left l5-s1 done.Trial implant inserted.Peek cage inserted laterally placed.Injection of local anesthesia.Tube retractors removed.Pedicle screws inserted on both ls-s1.Rods inserted bilaterally while checking x-rays.Noted good implant placement.Final screw tightening done.Wash.Closure by layer.Dressing.Endof procedure.Operation finding: opll noted at l5-s1: disc osteophyte complex impinging on bilateral s1 traversing nerve roots.(b)(6) 2023: pre-operative diagnosis: implant failure ls pedicle screw; s/p minimally invasive spine surgery transforaminal lumbar lnterbody fusion ls-51 tor spondylolytic spondylolisthesis ls-51 (b)(6) 2023 procedure technique: patient placed on general anesthesia.Intraop neuromonitoring devices put in place.Patient placed prone on spine table, ortho prep and drapes done.Extension about 1cm of right sided wound, deepened, implants visualized.51 set screw removed; right rod removed.Broken ls pedicle screw removed after reinsertion of guide wire.Decompression done and fibrous tissues removed.L5 and 51 nerve roots visualized and adequately decompressed.L5-s1 interspace at the right prepared, previous peek cage readjusted.New peek cage (10mm x 22mm) inserted from right side.X-rays checked; good position of interbody cages noted.Washing done, allograft inserted around the peek cage, vancomycin powder applied at l5-s1 interspace right, left sided incision extended and deepened.Screws visualized.Left side interspace decompressed and nerve roots checked, noted adequate decompression, new pedicle screw (7.5mm x 50mm) inserted at the right ls.Attachments for reduction and rod insertion placed over the 4 pedicle screws.Rods inserted bilaterally, note of broken ls screw at the left side, new pedicle screw (7.5mm x 50mm) inserted at the left ls.Attachments for reduction and rod insertion placed over the 4 pedicle screws rods inserted bilaterally reduction of listhesis done.Xrays checked.Final screw tightening.Vancomycin powder applied on both incisions, closure by layer.Dressing.End of procedure.Operative findings: detached pedicle screw head to neck at right l5; detached pedicle screw head to neck at left ls upon reduction of listhesis.

• Brand Name: CD HORIZON® SPINAL SYSTEM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• Manufacturer (Section G): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• Manufacturer Contact: glen belmer ; 1800 pyramid place; memphis, TN 38132 ; 6122713209
• MDR Report Key: 18515645
• Report Number: 1030489-2024-00046
• Device Sequence Number: 17811506
• Product Code: KWP
• UDI-Device Identifier: 00885074031156
• UDI-Public: 00885074031156
• Combination Product (Y/N): N
• Initial Reporter Country: RP
• PMA/510(K) Number: K032265
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/21/2024

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: 7576545
• Device Catalogue Number: 7576545
• Device Lot Number: H5809045
• 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: 12/20/2023
• Supplement Date Received by Manufacturer: 01/13/2024; 03/04/2024; 05/31/2024
• Initial Report FDA Received Date: 01/16/2024
• Supplement Report FDA Received Date: 01/25/2024; 03/21/2024; 06/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2022
• 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: Required Intervention
• Patient Sex: Female