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

Model Number	7576540
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from healthcare provider (hcp) via a manufacturer representative regarding a patient having mistlif spinal therapy.It was reported that the legacy screw tulip head had been separated from screw body.While implanting the product to patient body the surgeon found some discrepancy on checking at c arm images.The damaged screw was immediately explanted from patient body.And another screw was placed.There was no patient symptom reported.There were no further complications reported regarding the event.Allergies: not known chief complaints and duration: lower back pain radiating to b/l lower limb (l>r) for last 5-6 months.History of presenting illness: (b)(6), female, klclo htn, dyslipidemia, presented with lower back pain radiating to b/l lower limb (l>r) for last 5-6 months which are progressive in nature.No h/o fall, trauma, loc, convulsion, nausea, vomiting, chest pain limb weakness.Bowel and bladder habits are normal.Mri revealed l4-l5 listhesis.Past medical history: klclo htn, dyslipidemia.
Additional Manufacturer Narrative
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
• Manufacturer (Section G): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• Manufacturer Contact: glen belmer ; 1800 pyramid place; memphis, TN 38132 ; 6122713209
• MDR Report Key: 13665929
• Report Number: 1030489-2022-00206
• Device Sequence Number: 5466424
• Product Code: KWP
• UDI-Device Identifier: 00885074031132
• UDI-Public: 00885074031132
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K032265
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/04/2022

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: 7576540
• Device Catalogue Number: 7576540
• Device Lot Number: H5691039
• 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: 02/05/2022
• Initial Report FDA Received Date: 03/04/2022
• Date Device Manufactured: 06/19/2021
• 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
• Patient Age: 48 YR
• Patient Sex: Female