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	6534530
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Neither the device nor films of applicable imaging studies were 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 underwent olif(oblique lateral interbody fusion) at l3/4/5, tlif(transforaminal lumbar interbody fusion) at l5/s and pps(percutaneous pedicle screw placement) at l3-s due to spinal canal stenosis.Intra-op, the set screws of l3 and s which had been applied compression was loose after the final tightening.The set screws were not tightened after the final tightening.The set screws were tightened again with a t27 driver and the procedure was finished.There was a delay of less than 60 mins in overall procedure time.There were no patient symptoms or complications reported as a result of this event.

• 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: 10231465
• Report Number: 1030489-2020-00817
• Device Sequence Number: 16929715
• Product Code: NKB
• UDI-Device Identifier: 20643169885831
• UDI-Public: 20643169885831
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K170679
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/06/2020

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: 6534530
• Device Lot Number: H5595311
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2020
• Initial Report FDA Received Date: 07/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1