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

Catalog Number	54840006545
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Neither the device nor films of applicable imaging studies were 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 posterior lumbar fusion surgery at l4-s1.Post-op, screw broke.As a result, a revision surgery was performed and the screw was explanted.No fragment of the implant remained in the patient.The surgeon said the patient had taken a fall a year and a half ago and he said the broken screws were probably a result of the fall.
Additional Manufacturer Narrative
Due to imdrf harmonization, some previously submitted device, method, result, and conclusion codes related to this event may have been updated.Product analysis result: visual optical microscopic dimensional visual review confirms screw breakage two threads down just below the head.Visual and microscopic examination of the mas head identified witness marks.Ratchet marks on the fracture surface are aligned with the area of witness marks and deformation, consistent with loading.Dimensional examination of the bone screw neck orientation suggest maximum angulation may have been exceeded.Visual and optical examination of the area of fracture initiation did not identify a pre-existing surface defect near the area of crack origination that could contribute to crack propagation.Some fracture surface smearing is noted.Microscopic examination of the fracture surface identified a fairly flat fracture surface with multiple ratchet marks near the area of crack propagation.Dimensional examination of the major and minor diameters of the bone screw confirm relevant bone screw dimensions are within print specification.Three to four threads of the screw have been damaged from possible removal of the screw.The above observations are consistent with bend stress overload.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: 7482717
• Report Number: 1030489-2018-00633
• Device Sequence Number: 144325
• Product Code: NKB
• UDI-Device Identifier: 00613994579614
• UDI-Public: 00613994579614
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K091974
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2019

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: 54840006545
• Device Lot Number: H5167312
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2018
• Initial Date Received by Manufacturer: 04/04/2018
• Supplement Date Received by Manufacturer: 01/02/2019
• Initial Report FDA Received Date: 05/03/2018
• Supplement Report FDA Received Date: 02/01/2019
• 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 Weight: 117