MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC ELEVATE SPINAL SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number 8657001

Device Problems Break (1069); Mechanics Altered (2984)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/08/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information received form healthcare provider via manufacturer representative regarding an event happened during intra-op for a patient undergoing a procedure of transforaminal lumbar interbody fusion.It was reported that, revision surgery was performed on 8th feb to remove/replace a screw and advance the interbody cages anterior.The screw was redirected without issue.The surgeon tried to re-attach the elevate inserter to the elevate cage to collapse the device.But was unable to attach.Then, the surgeon used the elevate inserter to impact the cage to advance anteriorly.Upon impaction, the tip of the inserter broke off.The surgeon searched for the fragment with forceps and microscope as well as under fluoroscopy but unable to retrieve fragment.The fragment was not identified under fluoroscopy, then he used a standard tamp and was able to advance the cage.After the initial procedure, radiculopathy was not relieved which caused the surgeon to re-operate.The therapy involved during this event was l4-s1 tlif.There was a delay of approximately 10 minutes occurred as a result of inserter breakage.There were no patient symptoms or complications associated with this event.There was no additional treatment or surgery performed to patient as result of this event.

Manufacturer Narrative

H3: product analysis of product #: 8657001, lot #: em16a014.Analysis summary: visual and optical inspection confirmed one of the prongs at the tip of the inserter has broken.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.

• Brand Name: ELEVATE SPINAL SYSTEM
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• MDR Report Key: 11391509
• MDR Text Key: 234035483
• Report Number: 1030489-2021-00268
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 00643169432178
• UDI-Public: 00643169432178
• Combination Product (y/n): N
• PMA/PMN Number: K142559
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8657001
• Device Catalogue Number: 8657001
• Device Lot Number: EM16A014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2021
• Date Manufacturer Received: 07/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 27 YR