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

Catalog Number	6534530
Medical Device Problem Codes	Material Deformation (2976); Migration (4003)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/29/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
It was reported that post-op, the set screw on the right side backed out, and the set screw on the left side loosened.As to the looseness of the set screw on the left side, it was found that the set screw had loosened at the time of checking during the operation.Hence on (b)(6) 2020, revision surgery performed in which both the set screws were removed and were placed again.On the right side, rod bending was performed additionally because the rod had been unstable to the extent that the rod was on the same level as the screw head.There was no delay in overall procedure time.It was observed after operation through product image that both screws were deformed and burred at the tips, rubbed at the threads, and second screw had scratches and deposits on the threads.Both had no major scratches on the thread.Patient complications are unknown at this time.
Additional Manufacturer Narrative
Product analysis results: visual and optical inspection did not reveal any damage to the female torx head or the threads of the set screw.Functional check with a sample bone screw confirmed the set screw was able to thread into the head of the screw without any issue.No signs of off axis/ uneven wear on the bottom surface from the seating of the rod.The screw appears to function as intended.No fault found if information is provided in the future, a supplemental report will be issued.

• Brand Name: CD HORIZON SOLERA 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: 9748696
• Report Number: 1030489-2020-00195
• Device Sequence Number: 3029442
• Product Code: NKB
• UDI-Device Identifier: 20643169885831
• UDI-Public: 20643169885831
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K170679
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2020

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 Catalogue Number: 6534530
• Device Lot Number: H5573657
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2020
• Initial Date Received by Manufacturer: 01/30/2020
• Supplement Date Received by Manufacturer: 04/21/2020
• Initial Report FDA Received Date: 02/25/2020
• Supplement Report FDA Received Date: 04/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention