MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC PIVOX¿ OBLIQUE LATERAL SPINAL SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT,

Model Number 2161001

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/15/2021

Event Type  malfunction  

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 spinal therapy.It was reported that the end of the threaded inserter broke off during impaction of the inserter while placing the interbody cage.The surgeon noticed the broken piece and it was locked into the connection on the back of the cage and not going anywhere.The surgeon tried to remove, but ultimately thought that could potentially displace the properly placed implant and that it wasn't worth the risk.The broken piece would not affect the end result of the procedure and was not at risk of falling out into the patient post op.There were no symptoms reported.There were no further complications reported regardingthe event.

Manufacturer Narrative

B5: event description updated with the additional 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.

Event Description

The fragment remained in the actual implant, so its still in the patient body.No additional surgery needed.Procedure or therapy performed was olif.

Manufacturer Narrative

H3: product analysis product id# 2161001, lot no.# nm19h058.Visual and optical inspection confirmed the instrument is broken several threads down from the distal tip of the threaded rod.No surface defect identified that could contribute to crack propagation.Microscopic examination of the fracture surface finds a fairly brittle fracture with no indication of fatigue consistent with overload.This type of damage 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: PIVOX¿ OBLIQUE LATERAL SPINAL SYSTEM
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT,
• 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: 13148617
• MDR Text Key: 288819184
• Report Number: 1030489-2022-00011
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 00643169639607
• UDI-Public: 00643169639607
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152277
• 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,Followup
• Report Date: 06/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2161001
• Device Catalogue Number: 2161001
• Device Lot Number: NM19H058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/18/2019
• 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: 74 YR
• Patient Sex: Male