MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG VERTEX RECONSTRUCTION SYSTEM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Model Number	6958824
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
On (b)(6) 2020, mpxr 751785 (rep, hcp, for): information was received from a healthcare provider via manufacturer representative regarding a patient with an indication of atlantoaxial dislocation in need of open reduction by posterior atlantoaxial dislocation, iliac bone grafting and fusion procedure used in spinal therapy.It was reported that the device has broken.There were no patient symptoms reported.There were no fragments in the patient reported.There were no further complications reported regarding the event.On (b)(6) 2020, email (rep, hcp): additional information was received regarding the event.It was reported that during screwing, the screw shaft was bent.The product come in contact with the patient and half of the screw rod implanted to the vertebral body.There was a delay of about 5 mins in overall procedure time reported.
Additional Manufacturer Narrative
Device evaluation summary: visual and optical inspection revealed the threaded shaft of the screw has been bent.It appears the screw was bent due to 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.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: VERTEX RECONSTRUCTION SYSTEM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao,pr TN 00792
• MDR Report Key: 10533325
• Report Number: 1030489-2020-01274
• Device Sequence Number: 19531370
• Product Code: KWP
• UDI-Device Identifier: 00613994354754
• UDI-Public: 00613994354754
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K081297
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• 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): 03/04/2021

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: 6958824
• Device Catalogue Number: 6958824
• Device Lot Number: H5375128
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2020
• Supplement Date Received by Manufacturer: 02/23/2021
• Initial Report FDA Received Date: 09/15/2020
• Supplement Report FDA Received Date: 03/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 81 YR