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

Catalog Number	7576545
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/23/2017
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 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 an unknown surgery due to unspecified reasons.Post-op, the thread and the head parts of the implanted screw were found to be separated from each other.No further details have been provided.
Additional Manufacturer Narrative
Additional information: x-ray image review result: post-op x-ray for minimally invasive l5-s1 fusion provided.X-ray shows separation of the tulip and screw after rod fixation and cupping.This is usually a result of the assembly where the components are joined.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Type of procedure in the initial surgery: transforaminal lumbar interbody fusion (tlif) the patient underwent revision surgery for replacing the defected screw with a new thicker one.No patient complications were reported as a result of this event.
Additional Manufacturer Narrative
Product analysis result: visual microscopic dimensional visual inspection confirms the (7576545-01) bone screw disassembled from the mas head.The ring (7545525-04) and crown (7546510-03) 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 mechanical force required for bone screw detachment.The remaining sheared through a 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: 7141465
• Report Number: 1030489-2017-02542
• Device Sequence Number: 1014369
• Product Code: KWP
• UDI-Device Identifier: 00885074031156
• UDI-Public: 00885074031156
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K032265
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/22/2018

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: 7576545
• Device Lot Number: H5383849
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2018
• Initial Date Received by Manufacturer: 11/24/2017
• Supplement Date Received by Manufacturer: 12/20/2017; 05/23/2018
• Initial Report FDA Received Date: 12/22/2017
• Supplement Report FDA Received Date: 01/19/2018; 06/22/2018
• 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: Required Intervention