MAUDE Adverse Event Report: MSD DEGGENDORF MFG CAPSTONE CONTROL SPINAL SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT,

Model Number	4011227
Medical Device Problem Code	Mechanics Altered (2984)
Health Effect - Clinical Codes	Undesired Nerve Stimulation (1980); Pain (1994)
Date of Event	06/23/2021
Type of Reportable Event	Serious Injury
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 provider (hcp) via manufacturer representative regarding patient spinal therapy for sagital imbalance.It was reported that when the surgeon tried to implant the cage and turn it in order to take the final position, the implant released from the inserter and as result the implant didn¿t implanted according to the directions given in the ifu/labelling.There was patient had sciatica pain, nerve compression and no further complications were reported.
Additional Manufacturer Narrative
H3: product analysis #(b)(4).:part # 4011227, lot # 51ch visual and optical inspection confirmed the implant has been damaged.The body has been twisted and the inserter attachment hole has been deformed.This type of damage is consistent with bend stress overload.Radiographic image review: ap lateral x-ray for tlsi posterior lumbar spinal fusion.Ap/lateral x-rays interbody grafts present l4-5 l5-s1.The l5-s1 device appears positioned posteriorly in the interbody space.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: CAPSTONE CONTROL SPINAL SYSTEM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT,
• Manufacturer (Section D): MSD DEGGENDORF MFG; wertstrasse 17; deggendorf 94469 ; GM 94469
• MDR Report Key: 12252355
• Report Number: 1030489-2021-00994
• Device Sequence Number: 3635133
• Product Code: MAX
• UDI-Device Identifier: 00643169108844
• UDI-Public: 00643169108844
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• PMA/510(K) Number: K120368
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/21/2024
• Device Model Number: 4011227
• Device Catalogue Number: 4011227
• Device Lot Number: 51CH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/05/2021
• Supplement Date Received by Manufacturer: 09/02/2021
• Initial Report FDA Received Date: 07/30/2021
• Supplement Report FDA Received Date: 09/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Weight: 85