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

Catalog Number	54410004540
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned to manufacturer for evaluation therefore we are unable to determine the definitive cause of event.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient was pre-operatively diagnosed with thoracic t4 vertebral fracture.The patient underwent internal fixation of thoracic vertebra reduction and internal fixation.Intra-op, the surgeon implanted the screw into the patient's thoracic vertebra.In the last process of closing the lock, the plug screw had not broken yet by itself, but the nail tail of the screw had broken.The surgeon performed the operation completely according to the normal manner in the operation.After the screw was broken, the surgeon removed the screw and continued the operation with the same specification screw.No fragments of the device remained inside the patient's body.No patient complications were reported as a result of the event.
Additional Manufacturer Narrative
One side of the fas head has fractured off.The direction of the fracture and damage to the threads indicate that the set screw was miss aligned during installation.The excessive force placed outwardly on the u channel appears to have caused the head to fracture.If information is provided in the future, a supplemental report will be issued.

• 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: 7499092
• Report Number: 1030489-2018-00652
• Device Sequence Number: 14002233
• Product Code: NKB
• UDI-Device Identifier: 00613994586766
• UDI-Public: 00613994586766
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K091974
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2018

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: 54410004540
• Device Lot Number: H5343739
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2018
• Initial Date Received by Manufacturer: 04/09/2018
• Supplement Date Received by Manufacturer: 08/22/2018
• Initial Report FDA Received Date: 05/09/2018
• Supplement Report FDA Received Date: 09/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 48 YR