MAUDE Adverse Event Report: MDT PUERTO RICO OPERATIONS CO, MED REL VENTURE ANTERIOR CERVICAL PLATE SYSTEM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Model Number	9790215
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Codes	Neurological Deficit/Dysfunction (1982); Movement Disorder (4412)
Date of Event	08/27/2020
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
Information was received from a consumer via field representative regarding a patient who undergone spinal therapy with a pre-operative diagnosis of cervical fracture.It was reported that after the first surgery, the patient developed neurologic symptoms and underwent a revision surgery the next day to remove the four screws of the first surgery.The products have been implanted in the patient, and the larger diameter screws have been used during the secondary revision surgery.The size of the screw implants that were implanted during the revision surgery was with diameter of 4.5.The second revision surgery was performed within 24 hours after the first surgery, and these screws can no longer be used.There was no device breakage and product utilized correctly according to the directions given in the ifu/labeling.No further complications were reported.
Additional Manufacturer Narrative
H3: analysis summary: visual and optical inspection of part # 9790215 lot # h5540481 did not reveal any damage to the threads of head of the screw.Dimensional inspection confirmed the screw was made to print.The screw appears to function as intended.No fault found.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: VENTURE ANTERIOR CERVICAL PLATE SYSTEM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): MDT PUERTO RICO OPERATIONS CO, MED REL; road 909, km. 0.4., barrio mar; humacao PR 00792
• MDR Report Key: 10533371
• Report Number: 2647346-2020-00028
• Device Sequence Number: 2803236
• Product Code: KWP
• UDI-Device Identifier: 00721902989322
• UDI-Public: 00721902989322
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K042922
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2021

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 Model Number: 9790215
• Device Catalogue Number: 9790215
• Device Lot Number: H5540481
• 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: 03/16/2021
• 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: 53 YR