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

Catalog Number	7576540
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/15/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product was not returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the r eported 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 minimally invasive procedure.Post-op, the screw broke and persistent infection in disc space l4/l5 and l5/s1 was observed.So a revision surgery was performed to explant the screw.No fragments of the broken part remains inside the patient.
Additional Manufacturer Narrative
Additional info: x-ray review: post of x-rays for l4-s1 percutaneous instrumentation for l5 compression fracture.There is no interbody graft or instrumentation to l5.Failure was likely the result of ongoing motion at the l5/lumbosacral junction.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Product analysis: visual inspection confirms the (7575540-01) bone screw disassembled from the mas head.The ring (7545525-04) and crown (7545510-03) are still assembled in the head.Microscopic examination of the mas assembly identified a portion of the retaining ring is fully seated but has been sheared through the cross-sectional area on both sides of the retaining ring gap, which would reduce the force required for bone screw detachment.The remaining sheared through the portion of the ring appears to be deformed and bent away from the head.The remaining portion of the retaining ring is still seated in the groove of the head.Dimensional inspection of the bone screw head diameter found to be within print specification.After completed analysis, no evidence was found that would suggest a defect in design or manufacturing of the implant.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: 7272522
• Report Number: 1030489-2018-00225
• Device Sequence Number: 16178895
• Product Code: KWP
• UDI-Device Identifier: 00885074031132
• UDI-Public: 00885074031132
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K032265
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/25/2018

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 Catalogue Number: 7576540
• Device Lot Number: H5233759
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2018
• Initial Date Received by Manufacturer: 01/25/2018
• Supplement Date Received by Manufacturer: 02/27/2018; 04/26/2018
• Initial Report FDA Received Date: 02/15/2018
• Supplement Report FDA Received Date: 03/06/2018; 05/25/2018
• 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; Required Intervention
• Patient Age: 74 YR
• Patient Weight: 85