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

Model Number	55840005540
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from multiple sources (manufacturer representative, healthcare provider, foreign) regarding a patient with back pain/nerve compression for posterior spinal instrumentation therapy at level 3.It was reported that screw broke post operatively. the screw shaft remain in patient body.Patient have schedule for removal in 2 weeks time.There was back pain as patient symptoms or complications as a result of this event. the surgery is not done to achieve fusion for this patient.The surgery is schedule on (b)(6) 2021.The instrument order from another surgeon in a different hospital for the revision case of the said patient.The procedure is to remove the broken implant inside patient¿s body.

• 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
• MDR Report Key: 12038785
• Report Number: 1030489-2021-00823
• Device Sequence Number: 3959726
• Product Code: KWP
• UDI-Device Identifier: 00613994971999
• UDI-Public: 00613994971999
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K113174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/22/2021

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: 55840005540
• Device Catalogue Number: 55840005540
• Device Lot Number: H5597482
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2021
• Initial Report FDA Received Date: 06/22/2021
• 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