MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG CD HORIZON FENESTRATED SCREW SET; CEMENT, BONE, VERTEBROPLASTY

Model Number	55750025540
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Extravasation (1842)
Date of Event	01/25/2021
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
Information was received from a healthcare provider via a manufacturer representative regarding a patient with pre-operative diagnosis of vertebra fracture.It was reported that the cement leak out into screw head instead of coming out at fenestrated screw holes.It happened in two screws.The cement was leaked at the posterior part of the vertebra and the surgeons was able to remove it during surgery.The procedure ended without any injury to the patient.There was delay of 30min in overall procedure time.There were no patient symptoms/complications associated with the event.There is no additional surgery planned.Type of procedure is plif with voyager with lordorsis correction and ligamanetotaxis.

• Brand Name: CD HORIZON FENESTRATED SCREW SET
• Common Device Name: CEMENT, BONE, VERTEBROPLASTY
• Manufacturer (Section D): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• MDR Report Key: 11331973
• Report Number: 1030489-2021-00208
• Device Sequence Number: 858609
• Product Code: NDN
• UDI-Device Identifier: 00763000149574
• UDI-Public: 00763000149574
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K201362
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/16/2021

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 Expiration Date: 05/06/2025
• Device Model Number: 55750025540
• Device Catalogue Number: 55750025540
• Device Lot Number: H5610603
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2021
• Initial Report FDA Received Date: 02/16/2021
• 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: Other
• Patient Age: 51 YR