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	6540530
Medical Device Problem Codes	Material Deformation (2976); Migration (4003)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product analysis- the nod of the set screw is worn from the rod rubbing against it.Microscopic review reveals heavy witness marks on one side of the mas saddle from the rod moving inside the mas screw head.On the opposite side of the saddle the machine lines can still be seen with little to no witness marks.This indicates that the rod was angulated in the head of the mas screw head and could have allowed the rod to come out of the mas head with the set screw still in place.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient underwent posterior spinal fusion (psf), lateral due to kyphosis, spondylosis, radiculopathy, stenosis.Post-op, the set screw pulled away from rod.No malfunction was noted for the rod.The constructs were explanted in a revision surgery.
Additional Manufacturer Narrative
X-ray review- multiple post-op x-rays from posterior spinal instrumentation (levels unknown, unable to visualize upper level in provided images) show progressive slip of one of the rods out of the screw.This happened by the 3 month post-op image before fusion would be expected to have occurred.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: 8521561
• Report Number: 1030489-2019-00427
• Device Sequence Number: 2675916
• Product Code: NKB
• UDI-Device Identifier: 00643169750241
• UDI-Public: 00643169750241
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K170679
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2019

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: 6540530
• Device Lot Number: H5415469
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2019
• Initial Date Received by Manufacturer: 03/27/2019
• Supplement Date Received by Manufacturer: 04/30/2019
• Initial Report FDA Received Date: 04/17/2019
• Supplement Report FDA Received Date: 05/09/2019
• 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
• Patient Age: 54 YR
• Patient Weight: 97