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

Catalog Number	54410006545
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
"since the device was not 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
Type of procedure: posterior fusion.Product status: explanted-complete.It was reported that intra-operatively, the fas screw was broken while final tightening.The broken screw was removed and replaced with another and procedure was completed.The device came in contact with the patient.No fragment of the implant or instrument remaining in the patient.No patient complications were associated with the reported event.Update received on 18 jun 2018: screw head was broken.Broken part of screw was discarded.
Additional Manufacturer Narrative
Product analysis: one side of the fas head has broken off from what appears to be outward pressure placed on the head, from misalignment of the set screw.There are signs of thread damage and the fracture appears to move outwards.If information is provided in the future, a supplemental report will be issued.

• 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: 7612644
• Report Number: 1030489-2018-00863
• Device Sequence Number: 1555230
• Product Code: NKB
• UDI-Device Identifier: 00613994585738
• UDI-Public: 00613994585738
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K091974
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2018

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: 54410006545
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2018
• Initial Date Received by Manufacturer: 05/20/2018
• Supplement Date Received by Manufacturer: 08/21/2018
• Initial Report FDA Received Date: 06/19/2018
• Supplement Report FDA Received Date: 08/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 80 YR