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

Catalog Number	54840016545
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); Unspecified Infection (1930)
Date of Event	12/11/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Month and year are valid.The device was not returned to manufacturer for evaluation therefore we are unable to determine the definitive cause of event.Products from multiple manufacturers might be implanted during the procedure.Although it is unknown if any of the devices contributed to the reported event, we are filing this mdr for notification purposes.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient underwent transforaminal lumbar interbody fusion.Reportedly post-op, s1 screw broke below tulip.The patient underwent revision surgery for removal of hardware and re-instrumentation.The surgeon performed an anterior lumbar interbody fusion and a revision posterior fusion.No fragments of the devices remained inside the patient's body.The patient did not achieve solid fusion.The patient tested positive for gram negative bacilli.
Additional Manufacturer Narrative
A single post op x-ray was provided.Date post-op unknown.No screw fracture is observed, but the interbody graft appears to be displaced anteriorly.A surgical site infection may have attributed to construct failure by report.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Product analysis: visual examination of the mas bone screw confirmed bone screw complete fracture at the neck of the bone screw, just below the head.Visual and optical inspection of the bone screw surface did not identify witness marks or other damage near the fracture surface initiation area which could contribute to crack propagation.Optical examination of the fracture surface noted smearing and damage.Microscopic examination of the fracture surface identified progressive striations at all undamaged areas, which are indicative of cyclic fatigue.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: 7174407
• Report Number: 1030489-2018-00032
• Device Sequence Number: 19279126
• Product Code: NKB
• UDI-Device Identifier: 00613994579621
• UDI-Public: 00613994579621
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K091974
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/26/2018

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: 54840016545
• Device Lot Number: H5328778
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2018
• Initial Date Received by Manufacturer: 12/11/2017
• Supplement Date Received by Manufacturer: 01/30/2018; 03/30/2018
• Initial Report FDA Received Date: 01/09/2018
• Supplement Report FDA Received Date: 02/14/2018; 04/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ROD, SET SCREW
• Outcome Attributed to Adverse Event: Other; Required Intervention