MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG CD HORIZON; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Model Number 75447540

Device Problems Break (1069); Use of Device Problem (1670)

Patient Problems Pain (1994); Device Embedded In Tissue or Plaque (3165)

Event Date 10/01/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from distributor via field representative regarding patient with symptoms of spondylolisthesis at l5-s1 involved in spinal therapy.Levels implanted- l4 - s1 it was reported that during normal use, spinal screw broke.They made an incision in the midline, disinserted the muscle plane, and exposed the implanted material.They proceeded to remove the crosslink, then remove the break offs, then the bars and remove the crowns of the broken screws from s1, then remove the 2 integral screws from l4 and tried to explant the threaded portion of the s1 screws that were still implanted but due to the level of fusion and not having a suitable surface for holding, the doctor left the material in s1.Product was not utilized correctly according to the directions given in the ifu/labeling.Patient symptoms or complications was reported as a result of this event.Pain was reported.The screw thread was implanted on s1.No additional surgery/treatment performed as a result of this event.Product was explanted partially.Patient is alive and no injury.On 2021-feb-23, received additional information that event was revision surgery to explant broken screw.Patient was asymptomatic until 3 month ago when they started with pain that was progressing.Broken fragment is at implanted level.There was no arthrodesis at the level of instrumentation, also spondylolisthesis was reported at l5 ¿ s1 level, but the screws were placed on l4 and s1 there¿s no screws at the level of the spondylolisthesis.There was no delay in overall procedure time.There is no revision surgery planned again to explant fragments.Patient outcome after revision surgery was stable, without pain.

Manufacturer Narrative

Radiographic image review result- x-ray provided for l4-s1 posterior spinal fusion.No instrumentation is present in l5.A grade i spondylolisthesis l5-s1 is present.Both of the sacral screws have fractured.No interbody device is present.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from distributor via field representative regarding patient with symptoms of spondylolisthesis at l5-s1 involved in spinal therapy.Levels implanted- l4 - s1 it was reported that during normal use, spinal screw broke.They made an incision in the midline, disinserted the muscle plane, and exposed the implanted material.They proceeded to remove the crosslink, then remove the break offs, then the bars and remove the crowns of the broken screws from s1, then remove the 2 integral screws from l4 and tried to explant the threaded portion of the s1 screws that were still implanted but due to the level of fusion and not having a suitable surface for holding, the doctor left the material in s1.Product was not utilized correctly according to the directions given in the ifu/labeling.Patient symptoms or complications was reported as a result of this event.Pain was reported.The screw thread was implanted on s1.No additional surgery/treatment performed as a result of this event.Product was explanted partially.Patient is alive and no injury.On (b)(6) 2021, received additional information that event was revision surgery to explant broken screw.Patient was asymptomatic until 3 month ago when they started with pain that was progressing.Broken fragment is at implanted level.There was no arthrodesis at the level of instrumentation, also spondylolisthesis was reported at l5 ¿ s1 level, but the screws were placed on l4 and s1 there¿s no screws at the level of the spondylolisthesis.There was no delay in overall procedure time.There is no revision surgery planned again to explant fragments.Patient outcome after revision surgery was stable, without pain.On (b)(6) 2021, received additional information that therapy involved was spinal fixation without fusion.

Manufacturer Narrative

Additional information: b5, g3.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 SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• MDR Report Key: 11479193
• MDR Text Key: 241405486
• Report Number: 1030489-2021-00339
• Device Sequence Number: 1
• Product Code: KWP
• UDI-Device Identifier: 00885074134208
• UDI-Public: 00885074134208
• 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,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 04/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 75447540
• Device Catalogue Number: 75447540
• Device Lot Number: H5297901
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR