MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG CD HORIZON SPINAL SYSTEM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Catalog Number	55840007550
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product was not returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.X-ray review results: post-op ap/lateral x-rays for l3-s1 fusion were provided.No interbody grafts are present.Hardware placement appears appropriate.The s1 screws are fractured bilaterally.Fusion status is unknown.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient underwent l3-s1 fusion and decompression due to spinal stenosis, congenital spine deformity and spondylolisthesis.The alleged screw was implanted in this surgery.Decompression was done first, pedicle markers were used to determine screw placement via x-ray.Pedicles were measured and screws were placed.Screws looked good on final x-ray before closing.A cros slink was also used between l4 and l5 levels.On an unknown date, post-op, s1 screws were found to be broken bilaterally.This problem was discovered during patient follow up visit somewhere between 3 months and 6 months after the surgery.No fall or other traumatic event was reported which could have caused the breakage.No patient complications have been reported due to this event.The broken screws are still implanted in the patient; and the patient does not wish to have another surgery to remove the broken hardware.A ct has been ordered to see if the patient has acquired a solid fusion.

• Brand Name: CD HORIZON SPINAL SYSTEM
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• MDR Report Key: 9415524
• Report Number: 1030489-2019-01378
• Device Sequence Number: 16562005
• Product Code: NKB
• UDI-Device Identifier: 00643169004351
• UDI-Public: 00643169004351
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: K113174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/05/2019

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 Catalogue Number: 55840007550
• Device Lot Number: H5450365
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2019
• Initial Report FDA Received Date: 12/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 113