MAUDE Adverse Event Report: MDT PUERTO RICO OPERATIONS CO, MED REL CD HORIZON; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Model Number 75446545

Device Problem Material Fragmentation (1261)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/09/2021

Event Type  malfunction  

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 Description

Information was received from a health care professional via manufacturer representative regarding a screw used in lumbar discectomy with spinal canal decompression, fusion and internal fixation.Pre-operative diagnosis for this procedure was lumbar spinal stenosis, lumbar disc herniation, lumbar spondylolisthesis, type 2 diabetes.It was reported that the screw tip is broken and fell off, no fragment of the implant remaining in the patient.During the surgical screw implantation process, the screw tip fell off when the screw was screwed in, and the agent immediately replaced a new screw to continue the implantation no patient symptoms or complications as a result of this event.There was a delay of less than 60 minutes.

Manufacturer Narrative

H3: product analysis #(b)(4) lot# h5596147 visual and optical and dimensional examination of the implant confirmed the screw has been disassembled.Unable to determine root cause of the foregoing event from the available information.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
• Type of Device: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): MDT PUERTO RICO OPERATIONS CO, MED REL; road 909, km. 0.4., barrio mar; humacao PR 00792
• MDR Report Key: 11600684
• MDR Text Key: 243404343
• Report Number: 2647346-2021-00018
• Device Sequence Number: 1
• Product Code: KWP
• UDI-Device Identifier: 00885074134123
• UDI-Public: 00885074134123
• Combination Product (y/n): N
• PMA/PMN Number: K042025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 75446545
• Device Catalogue Number: 75446545
• Device Lot Number: H5596147
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2021
• Date Manufacturer Received: 10/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 62 YR