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

Model Number 7576545

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/26/2021

Event Type  Injury  

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 Description

The information was received from health care professional via a manufacturing representative regarding a patient with revision of the surgery to remove old screws out for longitude i spinal therapy.It was reported that the half-threaded tulip screw broke, the lower part of the screw thread remained in the patient.Fragment of the implant or instrument remaining in the patient.

Manufacturer Narrative

Part # 7576545; lot # h5584161 visual and optical inspection revealed the top portion of the crown of the screw has been worn from the seating of the rod and the bone screw has been separated from the head of the screw.The c ring is still attached but damaged.The crown has been pushed down through the saddle of the screw.The head of the bone screw has some wear rings and indentions from the screw head.This type of damage is consistent with the screw being implanted at an over angulated position causing the bone screw to separate from the saddle of the screw.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
• Type of Device: 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: 11549696
• MDR Text Key: 241696818
• Report Number: 1030489-2021-00385
• Device Sequence Number: 1
• Product Code: KWP
• UDI-Device Identifier: 00885074031156
• UDI-Public: 00885074031156
• Combination Product (y/n): N
• PMA/PMN Number: K032265
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7576545
• Device Catalogue Number: 7576545
• Device Lot Number: H5584161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2021
• Date Manufacturer Received: 06/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention