MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC CD HORIZON® SPINAL SYSTEM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Model Number	9010000849
Medical Device Problem Codes	Break (1069); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a healthcare provider (hcp) via manufacturer representative regarding a patient with an unknown indication for pps.It was reported that the rod gripping was weak. when turned the dial to make adjustments, the mechanism of one of the two instruments broke and the shaft inside was broken. product will be returned.The patient was not associated with this event.There were no further complications reported as a result of this event.Additional information received from manufacturer representative that the gripping of the rod inserters that are long-term consignments was loose.According to surgical technique, the strength was adjusted without gripping rod.The internal mechanism of one inserter was damaged, and another one was not damaged, but the gripping force did not improve much.It was managed to deal with the operation by using the rod inserter that did not damage, and the operation was completed.Additional information received from manufacturer representative that the pre-op diagnosis was kyphosis.The products were used in the patient.There was no health injury.There was 10-15 minutes delay in the procedure due to the malfunction of mdt device.
Additional Manufacturer Narrative
Product analysis: part # 9010000849 lot # kh19m026 visual and optical inspection confirmed the inner shaft of the percutaneous rod has been broken at the base.The instrument appears to have been overloaded causing the shaft to break.This type of damage is consistent with excessive force placed on the instrument when locking the rod into the place.The tension screw may have been tightened all the way.Additional information: d9, g1, g3, h3, h6 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): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: glen belmer ; 1800 pyramid place; memphis, TN 38132 ; 6122713209
• MDR Report Key: 12055862
• Report Number: 1030489-2021-00837
• Device Sequence Number: 17171345
• Product Code: KWP
• UDI-Device Identifier: 00643169359987
• UDI-Public: 00643169359987
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K162494
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 9010000849
• Device Catalogue Number: 9010000849
• Device Lot Number: KH19M026
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2021
• Supplement Date Received by Manufacturer: 11/18/2021
• Initial Report FDA Received Date: 06/24/2021
• Supplement Report FDA Received Date: 12/13/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/31/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown