MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC TSRH 3DX; PROBE

Model Number 8350294

Device Problem Material Twisted/Bent (2981)

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

Event Date 12/09/2021

Event Type  malfunction  

Event Description

Information was received from a healthcare provider via a manufacturer representative regarding a patient with pre-operative diagnosis for scoliosis, degeneration thoracic and lumbar spine.Procedure or therapy performed was olif.It was reported that the tip of the threaded shaft broke off during implantation of a cage at the disc space of l3/4 during an olif.During the posterior portion of the surgery, the tip of the instrument bent.The cage was implanted successfully.The tip of the threaded shaft remains inside the implant in the patient.Nothing happened to the patient.There were no symptoms reported.There were no further complications reported regarding the event.No additional surgery is planned.The shaft tip was safely secured inside the implant.There was no way to remove it.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare provider via a manufacturer representative regarding a patient with pre-operative diagnosis for scoliosis, degeneration thoracic and lumbar spine.Procedure or therapy performed was olif.It was reported that the tip of the threaded shaft broke off during implantation of a cage at the disc space of l3/4 during an olif.During the posterior portion of the surgery, the tip of the instrument bent.The cage was implanted successfully.The tip of the threaded shaft remains inside the implant in the patient.Nothing happened to the patient.There were no symptoms reported.There were no further complications reported regarding the event.No additional surgery is planned.The shaft tip was safely secured inside the implant.There was no way to remove it.

Manufacturer Narrative

Product analysis product id:8350294 lot no.: kh21b060 visual observation reveals that the tip of the probe has been bent from what appears to be overload.This is consistent with bend stress 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.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: TSRH 3DX
• Type of Device: PROBE
• 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: 13140383
• MDR Text Key: 285461974
• Report Number: 1030489-2022-00004
• Device Sequence Number: 1
• Product Code: HXB
• UDI-Device Identifier: 00613994282668
• UDI-Public: 00613994282668
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8350294
• Device Catalogue Number: 8350294
• Device Lot Number: KH21B060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/17/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Sex: Male