MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC CD HORIZON SPINAL SYSTEM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number	5484902
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2021
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 via a manufacturer representative regarding a patient with pre-operative diagnosis of compression fracture at l3.It was reported that when the ratchet handle and reduction nut driver were combined and the reduction nut was turned, the o ring and packing inside the reduction nut were broken.There was no delay in overall procedure time.There were no fragments of instruments left in patient's body.There were no patient symptoms or complications as a result of this event.When tightening the nut of the reported product and pushing down the rod, the ring of the extender connection part was broken before the rd signage appeared.The physician's view that there was not much gap between the rod and screw head, and it did not seem that the load was applied.A rod was placed on the sequential reducer on the cranial and caudal side of the reported location.After that, when a driver was inserted over the product, temporarily fixed, and then the driver was removed, the reported product was taken out from the extender together.
Additional Manufacturer Narrative
H6: product analysis 5484902 lot# em14m038 after visual and optical examination and functional testing, the treaded top section was received broken off the reducer.This appears this piece should have been held on with a ¿c¿ clip.The ¿c¿ clip failing or becoming overloaded would be a probable cause for the failure.This is consistent with overload.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.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: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• MDR Report Key: 11472077
• Report Number: 1030489-2021-00336
• Device Sequence Number: 4602876
• Product Code: NKB
• UDI-Device Identifier: 00643169177024
• UDI-Public: 00643169177024
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K122862
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2021

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: 5484902
• Device Catalogue Number: 5484902
• Device Lot Number: EM14M038
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2021
• Supplement Date Received by Manufacturer: 06/30/2021
• Initial Report FDA Received Date: 03/12/2021
• Supplement Report FDA Received Date: 07/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1