MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. VERTEX; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Model Number	6950315
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/18/2020
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 provider via a manufacturer representative regarding a patient with posterior cervical surgery.It was reported that the screw plug slipped.There was no fragment left or contact with the patient.There were no symptoms reported.
Additional Manufacturer Narrative
H3:product analysis: #703845340:part # 6950315, lot # h5496402.Visual and optical examination of the returned implant revealed the female hex of the screw has been damaged and deformed.The hex edges have been rounded off and stripped.There were no signs of thread damage on the set screws.The threads appear to be used but no signs of cross threading.This type of damage is consistent with torsional 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
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 10281242
• Report Number: 3004209178-2020-12277
• Device Sequence Number: 11476373
• Product Code: KWP
• UDI-Device Identifier: 00885074451237
• UDI-Public: 00885074451237
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K042498
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2020

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: 6950315
• Device Catalogue Number: 6950315
• Device Lot Number: H5496402
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2020
• Supplement Date Received by Manufacturer: 10/24/2020
• Initial Report FDA Received Date: 07/16/2020
• Supplement Report FDA Received Date: 10/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1