MAUDE Adverse Event Report: WARSAW ORTHOPEDICS TSRH® SPINAL SYSTEM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Model Number	828-083
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received from a regulatory body regarding a device used for non-cervical spine posterior pedicle fixation in a skeletally mature patient.It was reported that after 9 days of pain and weakness of both lower extremities due to heavy objects hitting the lower back, the patient was admitted to our hospital for treatment on (b)(6) 2020.On (b)(6) 2020, the patient underwent "open reduction, fusion and internal fixation of lumbar 3 vertebral fractures + posterior decompression of spinal canal".A total of 8 screws, 8 nuts and 1 titanium alloy rod were implanted during the surgery.The surgery went well and the patient was discharged from the hospital on (b)(6) 2021.On (b)(6) 2022, the patient's re-examination ct in our hospital showed that the titanium rod was broken.On (b)(6) 2022, the patient was admitted to (b)(6) for treatment.On (b)(6) 2022, the patient underwent "posterior lumbar decompression, bone grafting and internal fixation", and the broken rod was taken out successfully.On (b)(6) 2022, the patient was discharged from hospital.This product needed to be disinfected before use, and had no expiration date. there were no further complications reported regarding the event.Additional information was received that after the patient took out the internal fixation at (b)(6), it was found that the titanium rod was broken, so the patient called (b)(6).There were no malfunctions with the other products used in the initial surgery.The patient did not report complications or symptoms.
Additional Manufacturer Narrative
The complaint was reported via an ae report received from cfda.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: TSRH® SPINAL SYSTEM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• Manufacturer (Section G): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• Manufacturer Contact: glen belmer ; 1800 pyramid place; memphis, TN 38132 ; 6122713209
• MDR Report Key: 15733415
• Report Number: 1030489-2022-01010
• Device Sequence Number: 12570962
• Product Code: KWP
• UDI-Device Identifier: 00673978048680
• UDI-Public: 00673978048680
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K880215
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/04/2022

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: 828-083
• Device Catalogue Number: 828-083
• Device Lot Number: 0771264W
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2022
• Initial Report FDA Received Date: 11/04/2022
• Date Device Manufactured: 02/13/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 44 YR
• Patient Sex: Male