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

Catalog Number	55890007550
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product 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
It was reported that the patient presented with posterior junctional kyphosis; and underwent extension of correction from t9 to iliac.After putting in all new screws, when the surgeon was placing a new rod, he encountered some problem putting the rod into one of the old screw¿s tulip head.The tulip head was found tilted to one side and was unable to move as compared to the rest of the old screws.Hence, the alleged screw was removed; and was replaced with a new one.No patient complications were reported.

• 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: 9834446
• Report Number: 1030489-2020-00310
• Device Sequence Number: 3188713
• Product Code: NKB
• UDI-Device Identifier: 00643169057258
• UDI-Public: 00643169057258
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K113174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/16/2020

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: 55890007550
• Device Lot Number: H5421121
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2020
• Initial Report FDA Received Date: 03/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1