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

Model Number	55740007540
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received from a healthcare provider via a manufacturer representative regarding a rod and screws implanted in a patient.Procedure performed in the initial surgery was t9/s2 was fixated with psf from degenerative kyphoscoliosis.Pre-op diagnosis for the revision surgery was broken rod, sai set screw dislodgement on both sides, bilateral s1 screw and left sai screw loosening.Procedure performed in revision surgery was both sides of s1 screws and the left sai screw were replaced.It was reported that the initial surgery was performed on (b)(6) 2021, but due to the broken rod, reoperation was performed on (b)(6) 2021.A reoperation was performed because the rod was broken again, the set screw used for the sai screw came off, and the screw became loose.The physician requested that the screw head of the sai screw thread be checked for damage.There were no patient symptoms or complications as a result of this event.
Additional Manufacturer Narrative
Lot number for the product couldn't be identified clearly after explantation.Lot# confirmed to be one out of h5554648, h5644495 or h5651307.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: 14024669
• Report Number: 1030489-2022-00324
• Device Sequence Number: 6172102
• Product Code: KWP
• UDI-Device Identifier: 00613994996091
• UDI-Public: 00613994996091
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K202328
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/06/2022

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 Model Number: 55740007540
• Device Catalogue Number: 55740007540
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2022
• Initial Report FDA Received Date: 04/06/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male