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

Catalog Number	75446540
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/05/2019
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 underwent pedicle screw internal fixation and bone graft fusion due to lumbar spondylolisthesis.In tra-op, the screw broke.The implant came in contact with the patient.No fragment of the broken implant remained inside the patient.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Product analysis: visual evaluation revealed the screw has separated from the multi-axial head.Optical inspection confirmed the ring and crown were still assembled in the head.A portion of the ring has been sheared through the cross sectional area on each side of the retaining ring gap, with the remaining portion of the ring still seated in the groove of the head.Microscopic inspection confirmed witness marks on one side of the inner head consistent with severe angulation of the bone screw.Dimensional check confirmed bone screw head diameter to be within print specification.The above observations are consistent with overload as the mechanism of failure.If information is provided in the future, a supplemental report will be issued.

• 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: 8467807
• Report Number: 1030489-2019-00351
• Device Sequence Number: 1341145
• Product Code: KWP
• UDI-Device Identifier: 00885074134116
• UDI-Public: 00885074134116
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K042025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2019

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: 75446540
• Device Lot Number: H5318422
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2019
• Initial Date Received by Manufacturer: 03/05/2019
• Supplement Date Received by Manufacturer: 05/13/2019
• Initial Report FDA Received Date: 03/30/2019
• Supplement Report FDA Received Date: 06/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 13 YR