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

Model Number	55840016550
Medical Device Problem Codes	Failure to Align (2522); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2021
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 manufacturer representative regarding a patient with a pre-operative diagnosis of metal explant.It was reported that when surgeon tried to explant the screw, but it was very difficult because it seems "cold welded", and it was nearly impossible to insert the screw driver into the screw head.Product is explanted.There were no  patient symptoms or complications as a result of this event.The fracture had healed and was stable, the patient wanted the metal to be to removed.The screwhead was blocked by the plate partially and stuck.There was delay of about 25 - 30 min in overall procedure time, additional tools/ screwdriver were needed to remove the screw.There were no fragments left inside the patient.
Additional Manufacturer Narrative
H3:part # 55840016550; lot # h5398519 visual and optical inspection revealed the top portion of the crown of the screw has been worn from the seating of the rod.Functional inspection confirmed the screw head was locked in an angled position blocking the female torx of the screw.The crown has been pushed down through the saddle of the screw not allowing the head to pivot anymore.This is the normal issue when the bone screw is implanted.The female torx was not accessible due to the locked angle of the screw head/tulip.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: CD HORIZON SPINAL 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: 11824667
• Report Number: 1030489-2021-00618
• Device Sequence Number: 14530079
• Product Code: KWP
• UDI-Device Identifier: 00643169077294
• UDI-Public: 00643169077294
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K113174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• 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): 08/02/2021

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: 55840016550
• Device Catalogue Number: 55840016550
• Device Lot Number: H5398519
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2021
• Supplement Date Received by Manufacturer: 07/31/2021
• Initial Report FDA Received Date: 05/14/2021
• Supplement Report FDA Received Date: 08/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 90