MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG SOLERA VOYAGER 5.5; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number 6534530

Device Problem Material Deformation (2976)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/22/2020

Event Type  Injury  

Manufacturer Narrative

Product has been returned and analysis is yet to begin.A follow-up report will be sent once analysis is completed.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare professional (hcp) via a medtronic representative regarding a patient implanted with screws using a driver for a l3/5 olif and posterior spinal fixation (intra-op).It was reported that the tip of the driver that was broken at this time got stuck in the screw shaft, and because the tip was difficult to be removed during operation, screw was removed.During posterior spinal fixation, after screw was inserted, when an attempt was made to perform additional insertion of screw for adjusting the position by the reported driver, the tip of the driver broke and got stuck in the bone screw.Therefore, a short rod was placed and the screw was removed.The screw broke and there was no fragment of the screw remaining in the patient's body.The screw was never implanted (screw #1).When the set screw was pushed down in a state of short tab, the tab widened even though it was not cross-threaded, so the set screw became difficult to be pushed down.The size of tap was reduced by one size.In addition, since set screw idled when it was inserted, the set screw was removed and replaced with another screw.When checking the screw that was removed, it was found the tab was deformed.The set screw was discarded.The screw broke and there was no fragment of the screw remaining in the patient's body.The screw was never implanted (screw #2).During inserting screw additionally by the reported driver, the tip of the driver broke.The driver broke and there was no fragment of the driver remaining in the patient's body.The reason of the event is thought that since the driver was used for a patient with hard bones, the hardness of the tip is less than bone, so the tip broke.Screw #4 idled and the thread of screw #5 was damaged.The patient came in contact with the reported products.There were no patient symptoms or complications as a result of the event.The pre- op diagnosis was progress of degeneration, bladder disturbance, and radicular symptom at both sides of l5.The patient had severe bone sclerosis.The levels implanted were l3- l5.The reason for revision surgery was that fixation was performed at thoracic previously and this time, the operation was performed because symptom appeared at the lumbar level.The product was used without anextender because it was necessary to perform decompression and the procedure was changed to open.The hcp said that no method could be done due to the bone sclerosis.The date of initial surgery was (b)(6) 2020.The initial surgery was a thoracic decompression and posterior spinal fixation (th10/11).The initial surgery was performed using solera 4.75 spinal system.No health damage in the patient was reported.No further complications were reported/ anticipated.

Manufacturer Narrative

D3: update in mfg site d9: update in device return status h3: customer will not be returning the product as the customer just wants to keep the product.H6: update in patient code, eval.Code method, eval.Code result.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

Information was received from a healthcare professional (hcp) via a medtronic representative regarding a patient implanted with screws using a driver for a l3/5 olif and posterior spinal fixation.It was reported that the tip of the driver that was broken at this time got stuck in the screw shaft, and because the tip was difficult to be removed during operation, screw was removed.During posterior spinal fixation, after screw was inserted, when an attempt was made to perform additional insertion of screw for adjusting the position by the reported driver, the tip of the driver broke and got stuck in the bone screw.Therefore, a short rod was placed and the screw was removed.The screw broke and there was no fragment of the screw remaining in the patient's body.The screw was never implanted (screw #1).When the set screw was pushed down in a state of short tab, the tab widened even though it was not cross-threaded, so the set screw became difficult to be pushed down.The size of tap was reduced by one size.In addition, since set screw idled when it was inserted, the set screw was removed and replaced with another screw.When checking the screw that was removed, it was found the tab was deformed.The set screw was discarded.The screw broke and there was no fragment of the screw remaining in the patient's body.The screw was never implanted (screw #2).During inserting screw additionally by the reported driver, the tip of the driver broke.The driver broke and there was no fragment of the driver remaining in the patient's body.The reason of the event is thought that since the driver was used for a patient with hard bones, the hardness of the tip is less than bone, so the tip broke.Screw #4 idled and the thread screw #5 was damaged.The patient came in contact with the reported products.There were no patient symptoms or complications as a result of the event.The pre- op diagnosis was progress of degeneration, bladder disturbance, and radicular symptom at both sides of l5.The patient hadsevere bone sclerosis.The levels implanted were l3- l5.The reason for revision surgery was that fixation was performed at thoracic previously and this time, the operation was performed because symptom appeared at the lumbar level.The product was used without an extender because it was necessary to perform decompression and the procedure was changed to open.The hcp said that no method could be done due to the bone sclerosis.The date of initial surgery was (b)(6)2020.The initial surgery was a thoracic decompression and posterior spinal fixation (th10/11).The initial surgery was performed using solera 4.75 spinal system.No health damage in the patient was reported.The screw #1 and driver were replaced by medtronic products.No further complications were reported/ anticipated.

• Brand Name: SOLERA VOYAGER 5.5
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao,pr TN 00792
• MDR Report Key: 10639901
• MDR Text Key: 212485725
• Report Number: 1030489-2020-01387
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• PMA/PMN Number: K170679
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6534530
• Device Catalogue Number: 6534530
• Device Lot Number: H5618055
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 09/07/2020
• Date Manufacturer Received: 11/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention