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

Model Number	55740005545
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	11/29/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.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 spinal therapy.It was reported that there was a screw breakage in a revision surgery.There was a fragment left in the patient.They gave up the removal of the tip of the screw since it was near the spinal cord.An additional surgery performed as a result of this event.There were no further complications reported regarding the event.The relationship between the reported event and the use of medtronic product was unknown.Preop diagnosis is pjk.
Additional Manufacturer Narrative
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.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 spinal therapy.It was reported that there was a screw breakage in a revision surgery.There was a fragment left in the patient.They gave up the removal of the tip of the screw since it was near the spinal cord.An additional surgery performed as a result of this event.There were no further complications reported regarding the event.The relationship between the reported event and the use of medtronic product was unknown.Preop diagnosis is pjk.
Event or Problem Description
Information was received from a healthcare provider (hcp) via a manufacturer representative regarding a patient implanted with a screw in a revision surgery at (b)(6)for (b)(6).It was reported that there was a screw breakage in the revision surgery.There was a fragment left in the patient.Hcp gave up the removal of the tip of the screw since it was near the spinal cord.An additional surgery performed as a result of this event- extension from (b)(6): ttif.There were no patient symptoms or complications as a result of this event.There was no delay in overall procedure time and no in-patient hospitalization or prolongation of existing hospitalization necessary.The date of implant was (b)(6) 2017 and date of partial explant was (b)(6) 2021.The patient's medical history included hypertension, hyperlipidemia, internal use history: steroid, blood pressure medicine.No further complications were reported/ anticipated.
Additional Manufacturer Narrative
B5: event description updated d4: lot # corrected radiographic image review: a screw fragment is seen in one of the thoracic vertebral bodies.It¿s difficult to tell for the description if this happened during surgery or was part of the hardware failure necessitating revision.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: 13073958
• Report Number: 1030489-2021-01589
• Device Sequence Number: 5127515
• Product Code: KWP
• UDI-Device Identifier: 00613994995407
• UDI-Public: 00613994995407
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K202328
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2021
• Serviced by Third Party (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): 03/03/2022

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: 55740005545
• Device Catalogue Number: 55740005545
• Device Lot Number: UNKNOWN
• 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: 11/29/2021
• Supplement Date Received by Manufacturer: 12/29/2021
• Initial Report FDA Received Date: 12/23/2021
• Supplement Report FDA Received Date: 03/03/2022
• 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