MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC ELEVATE SPINAL SYSTEM; EXTRACTOR

Model Number 8657012

Device Problem Mechanics Altered (2984)

Patient Problems Cerebrospinal Fluid Leakage (1772); Muscle Weakness (1967); Seroma (2069); Numbness (2415); Unspecified Nervous System Problem (4426)

Event Date 12/23/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from healthcare professional via manufacturer representative regarding a patient having tlif due to lumbar spondylosis.It was reported that the patient had symptoms as a result of the event.The patient is alive with injury.Summary: it was reported that the removal device would not grip the cage and the insertion device did not have a strong enough hold on the cage that it could be useful to remove the cage.The left l4 screw was then repositioned as the prior screw had a suboptimal trajectory.At this time, it was noticed that there was a very small amount of csf leaking from the left ventral thecal sac where the cage had been removed and from the right side just below the right l4 nerve root.Surgical history includes lumbosacral l4 to s1 laminectomy, posterolateral fusion, l4-5 transforaminal lumbar interbody fusion pre-op diagnosis- lumbar spondylosis reported events: on (b)(6) 2020: moderate amount of air identified within the postoperative region posterior to the thecal sac at the level of the l3 and l4 vertebral bodies.On (b)(6) 2020: patient continues to have weakness in her lower extremities.Patient to be on flat bedrest until 1200 on (b)(6) secondary to csf leak.On (b)(6) 2020: intraoperative csf leak and repair.Leg weakness bilaterally.On (b)(6) 2020: leg weakness bilaterally.Hopeful discharge to ipr on monday.On (b)(6) 2020: ongoing le weakness/buttock numbness.Pt noted to have drainage when standing today.Placed on bedrest.Npo due to leakage from incision.Motor: minimal gross movement in lower extremities; minimal movement noted in right foot and toes greater than left.Sensation: decreased sensation to bilateral feet.On (b)(6) 2020: interventional neurology has been consulted for lumbar drain placement for csf leak, post-operatively.Persistent leg weakness on decadron on (b)(6) 2020: lumbar drain remains in place for management of csf leak.Remains on bedrest until (b)(6).On (b)(6) 2021: drain removed.Motor: 4/5 bilateral hf, 5/5 bilateral ke, minimal movement in bilateral feet - grossly unchanged from previous day.On (b)(6) 2021: immediate drainage reported when patient transitioned from sitting to standing.Bedrest restarted.On (b)(6) 2021: leakage from wound reported whenever patient is upright since the prior surgery.Even though patient is dry when she is flat unfortunately.Lumbar wound re-exploration, washout with nature, risks and benefits were discussed with patient.Findings: seroma no obvious csf leak on (b)(6) 2021: lumbar wound exploration performed patient seen and examined, resting in bed.Patient states that she has increased movement in lower extremities after surgery.On (b)(6) 2021: discharge planned.

Manufacturer Narrative

Product analysis: 8657012 lot# nm16f194 visual and optical examination identified that the tips of the instrument appears to be bent.The slap hammer attachment also appears to be bent.The circular protrusions appear to have a lot of wear.These observations are consistent with 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: ELEVATE SPINAL SYSTEM
• Type of Device: EXTRACTOR
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• MDR Report Key: 11431671
• MDR Text Key: 241401150
• Report Number: 1030489-2021-00308
• Device Sequence Number: 1
• Product Code: HWB
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• 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: 05/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8657012
• Device Catalogue Number: 8657012
• Device Lot Number: NM16F194
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2021
• Date Manufacturer Received: 05/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention