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

Catalog Number	54840017545
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Neither the device nor applicable imaging films were returned to the manufacturer for evaluation, therefore, the cause of the event cannot be determined.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 transforaminal lumbar interbody fusion (mis tlif) at l5-s1 due to lumbar degenerative disease.Post-operatively, screw broke and pain was observed.As a result, a revision surgery was performed and broken left s1 screw was explanted.No fragment of the implant remained in the patient.
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.There are witness marks on the head of the mas indicating that the head was fully angulated and touch the shaft of the bone screw at or near the area of crack propagation.Microscopic examination of the fracture surface noted smearing and damage.Microscopic examination of the fracture surface identified progressive striations in some undamaged areas, which are indicative of cyclic fatigue that could have been accelerated by steep angulation.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: 7543903
• Report Number: 1030489-2018-00751
• Device Sequence Number: 11311189
• Product Code: NKB
• UDI-Device Identifier: 00613994593351
• UDI-Public: 00613994593351
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K091974
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/26/2018

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: 54840017545
• Device Lot Number: H5231688
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2018
• Initial Date Received by Manufacturer: 05/15/2018
• Supplement Date Received by Manufacturer: 11/01/2018
• Initial Report FDA Received Date: 05/25/2018
• Supplement Report FDA Received Date: 11/26/2018
• 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
• Patient Age: 48 YR
• Patient Weight: 114