MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC CAPSTONE SPINAL SYSTEM; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Model Number	2990001
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a healthcare professional via a field contact regarding a patient with a pre-operative diagnosis of lumbar spinal canal stenosis, undergoing a posterior lumbar vertebra fusion procedure.It was reported that it was a patient with very hardened vertebral body end plate and relatively low intervertebral height.When inserting the pt cage into l4 / 5, the end plate was hardened and the intervertebral space was narrow, so it was inserted while hitting the inserter strongly with a plastic hammer.When talking about the inserter as a cage, one of the two claws of the inserter was missing.After checking with the image, it was confirmed that the broken inserter tip was in the intervertebral disc space.It had managed to get broken part off with hernia forceps.There was a delay of less than 60 min.Initial reporter information and patient information cannot be provided due to the restriction by the privacy regulation.Levels implanted: l4/5 when the reported inserter was removed after the cage was placed, the claw at the tip was broken on one side.Since the broken claw was collected, it did not remain in the patient¿s body.The cage used was 8x22 and is being inserted.Before placing the cage, the distractor was used up to 10 mm.
Additional Manufacturer Narrative
H2: additional information received stated in b5 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 or Problem Description
Information was received from a healthcare professional via a field contact regarding a patient with a pre-operative diagnosis of lumbar spinal canal stenosis, undergoing a posterior lumbar vertebra fusion procedure.It was reported that it was a patient with very hardened vertebral body end plate and relatively low intervertebral height.When inserting the pt cage into l4 / 5, the end plate was hardened and the intervertebral space was narrow, so it was inserted while hitting the inserter strongly with a plastic hammer.When talking about the inserter as a cage, one of the two claws of the inserter was missing.After checking with the image, it was confirmed that the broken inserter tip was in the intervertebral disc space.It had managed to get broken part off with hernia forceps.There was a delay of less than 60 min.Initial reporter information and patient information cannot be provided due to the restriction by the privacy regulation.Levels implanted: l4/5 when the reported inserter was removed after the cage was placed, the claw at the tip was broken on one side.Since the broken claw was collected, it did not remain in the patient¿s body.The cage used was 8x22 and is being inserted.Before placing the cage, the distractor was used up to 10 mm.The procedure was completed successfully.
Additional Manufacturer Narrative
H3: product analysis visual and optical inspection confirmed one of the tabs on 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: CAPSTONE SPINAL SYSTEM
• Common Device Name: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• MDR Report Key: 11522374
• Report Number: 1030489-2021-00366
• Device Sequence Number: 17143150
• Product Code: MQP
• UDI-Device Identifier: 00613994803061
• UDI-Public: 00613994803061
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K103731
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 2990001
• Device Catalogue Number: 2990001
• Device Lot Number: NM12F025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2021
• Supplement Date Received by Manufacturer: 04/01/2021; 10/05/2021
• Initial Report FDA Received Date: 03/19/2021
• Supplement Report FDA Received Date: 04/21/2021; 10/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1