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

Model Number	75446540
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/26/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from healthcare professional via manufacturer representative regarding a patient implanted with pedicle screw.The pre op diagnosis was herniated nucleus pulposus (hnp) (l5 -s1) and procedure involved was stabilitasion lumbar to illiac.It was reported that the patient had complaints of spinal pain and after an x-ray there was a broken screw in c1, the first operation of the pedicle screw was performed on (b)(6) 2019.A revision surgery was performed as a result of this event.The product was explanted will be replaced.There were no other complications reported.
Event or Problem Description
Information was received from healthcare professional via manufacturer representative regarding a patient implanted with pedicle screw.The pre op diagnosis was herniated nucleus pulposus (hnp) (l5 -s1) and procedure involved was stabilitasion lumbar to illiac.It was reported that the patient had complaints of spinal pain and after an x-ray there was a broken screw in s1, the first operation of the pedicle screw was performed on (b)(6) 2019.A revision surgery was performed as a result of this event.The product was explanted will be replaced.There were no other complications reported.
Additional Manufacturer Narrative
Event description 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.

• Brand Name: CD HORIZON
• 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
• MDR Report Key: 10424693
• Report Number: 1030489-2020-01105
• Device Sequence Number: 11497654
• Product Code: KWP
• UDI-Device Identifier: 00885074134116
• UDI-Public: 00885074134116
• Combination Product (Y/N): N
• Initial Reporter Country: ID
• PMA/510(K) Number: K042025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2020

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: 75446540
• Device Catalogue Number: 75446540
• Device Lot Number: H5486516
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2020
• Supplement Date Received by Manufacturer: 08/25/2020
• Initial Report FDA Received Date: 08/19/2020
• Supplement Report FDA Received Date: 09/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 36 YR