MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC UNKNOWN; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number MSB_UNK_SCREW

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/17/2023

Event Type  Injury  

Manufacturer Narrative

H6: 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.Qty.Of screws 4 nos.Section a: patient information cannot be included in regulatory report due to regional privacy regulations.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.

Event Description

Information was received from other, healthcare professional via a manufacturer representative regarding a patient with preoperative diagnosis for reoperation due to ps loosening.Procedure performed was c1/2 posterior fixation.This is a revision surgery.In (b)(6) 2023, c1/2 fixation was performed.It was replaced because the screw was loosened.It was reported that the set screw does not fit.Mas cross-link was used for c1 of c1/2.The final cross-link set screw does not fit when the procedure is performed according to the procedure manual.Repeated it many times, but it did not work, so it was replaced with the size m.It was removed once and the set screw could be fitted outside the surgical field, but after applying torque to the cross-link in the surgical field, the set screw could no longer fit.This phenomenon continued three times.There was no patient symptoms or complications as a result of this event.The relationship between the reported event and the use of medtronic products is unknown.In (b)(6) 2023 screws were placed.All of the infinity screws that fixed/held c1/c2 were loose, so a revision surgery was performed.All screws were removed and screws with a larger diameter were placed.The original screws were returned to the patient and cannot be obtained.Primary disease was unknown.Bone quality was unknown.The set screw can be attached outside the surgical field, but after applying torque to the cross-link in the surgical field, the set screw will no longer be inserted.

• Brand Name: UNKNOWN
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: glen belmer ; 1800 pyramid place; memphis, TN 38132 ; 6122713209
• MDR Report Key: 17718015
• MDR Text Key: 323040313
• Report Number: 1030489-2023-00634
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MSB_UNK_SCREW
• Device Catalogue Number: MSB_UNK_SCREW
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/17/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention