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

Model Number	75447535
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Muscle Weakness/Atrophy (1967); Pain (1994); Ambulation or Postural Difficulties (2544); Paresthesia (4421)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Radiographic image review for ap lateral images for l5 s1 and t11 l2 fusion- there is a spondylolisthesis at l5 s1.Both of the sacral screws are fractured.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a healthcare professional (hcp) via a distributor regarding multi axial screws implanted in a patient during spinal fixation at l5-s1 for material removal.It was reported that screws broke.Imaging studies were performed identifying bilateral sacral screw fracture.The patient had episodes of lower limb pain, bilateral paresthesia, decreased strength, and difficulty walking.A surgery for material removal and replacement of both sacral screws was performed.The date of implant was (b)(6) 2021 and date of explant was (b)(6) 2021.The patient's medical history includes approximately 1 year of having suffered a fall from stairs and traumatizing the lumbar region.So at the time of occlusion, a diagnosis of a l1 and l4-l5 fracture was made for which she was operated on.The patient heard a clicking sound after which he presented episodes of lower limb pain, bilateral paresthesia, decreased strength and difficulty walking.Patient denies fall and trauma prior to episodes of pain.No further complications were reported/ anticipated.
Additional Manufacturer Narrative
H6: additional information received stating that the reported products were discarded; eval.Code method updated accordingly.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
H6: additional information was received stating that the products were sent back; hence eval.Code method was 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.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.
Additional Manufacturer Narrative
H3: product analysis part# 75447535 ; lot# h5671870- visual examination revealed that the screw was broken about one thread down from the base of the bone screw head.Optical examination of the area of fracture initiation did not identify a pre-existing surface defect that could contribute to crack propagation.Some fracture surface smearing is noted.Microscopic examination of the fracture surface identified a fairly flat fracture surface with progressive striations consistent with cyclic fatigue.The threads of the broken lower portion of the screw have been damaged, possibly from the removal process.The above observations are consistent with cyclic fatigue followed by overload once the fatigue had weakened the material.H6: updated eval.Code method and eval.Code result post analysis 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.

• 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: 13017093
• Report Number: 1030489-2021-01555
• Device Sequence Number: 4948584
• Product Code: KWP
• UDI-Device Identifier: 00885074134192
• UDI-Public: 00885074134192
• Combination Product (Y/N): N
• Initial Reporter Country: ES
• PMA/510(K) Number: K042025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/23/2022

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: 75447535
• Device Catalogue Number: 75447535
• Device Lot Number: H5671870
• 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: 11/29/2021
• Supplement Date Received by Manufacturer: 01/27/2022; 02/24/2022; 12/15/2022
• Initial Report FDA Received Date: 12/16/2021
• Supplement Report FDA Received Date: 02/16/2022; 03/03/2022; 12/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/16/2021
• 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: 26 YR
• Patient Sex: Female
• Patient Weight: 57 KG