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

Catalog Number	6950315
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient presented with cervical spine instability post injury and anterior stabilization with fixation.He underwent the following cervical spinal stabilization procedures: posterior cervical instrumentation, fixation and fusion at c3-c6.On an unknown date, post-op, during standard post-surgical follow-up exam, the patient noted experiencing/ feeling a pop.Standard follow-up x-rays showed disengagement of set screw at the terminal, cephalad end of construct on patient's right side.Hence, a revision surgery was performed, in which the disengaged/ dislodged set screw was removed and replaced.No patient complications were reported as a result of this event.
Additional Manufacturer Narrative
H6: product analysis: macroscopic and optical examination revealed thread crest/flank damage; this damage appears to have initiated near the start of the thread and is evident around the damaged portion of the thread.Functional evaluation with a sample mas head found the set screw was still able to be fully threaded/engaged.This type of damage is consistent with misalignment of the mas head and set screw threads during construct assembly.Additional information: d10, g1, g2, h3, h6.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: 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 00792
• MDR Report Key: 9996399
• Report Number: 1030489-2020-00476
• Device Sequence Number: 14371625
• Product Code: KWP
• UDI-Device Identifier: 00885074451237
• UDI-Public: 00885074451237
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K052734
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2020

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 Catalogue Number: 6950315
• Device Lot Number: H5356849
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2020
• Initial Date Received by Manufacturer: 03/26/2020
• Supplement Date Received by Manufacturer: 07/22/2020
• Initial Report FDA Received Date: 04/24/2020
• Supplement Report FDA Received Date: 07/24/2020
• 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: 17 YR
• Patient Weight: 91