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

Catalog Number	54840006550
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/11/2017
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.
Event or Problem Description
It was reported that the patient underwent posterior lumbar fusion due to stenosis, radicular symptoms.Post-op, on (b)(6) 2017, the screw on the left side at s1 pedicle was reported for breakage.Patient expressed pain after surgery without any trauma involved.Explant of the same has bee planned on (b)(6) 2017.
Additional Manufacturer Narrative
X-ray review: plain x-rays were provided for l4-s1 posterior fusion interbody grafts at l4-5 and l5-s1.X-rays were 2 months post fusion procedure.So, presumably, bony fixation had not occurred.One of the s1 screws was broken.Hardware placement and size appeared appropriate.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Product analysis: visual and microscopic examination of mas bone screw confirms breakage ~5 threads from the base of the bone screw head.Microscopic examination reveals secondary (post-fracture) damage to the fracture surface.Undamaged areas of fracture surface revealed convex striations through the cross-sectional area, consistent with cyclic fatigue.The above observations are consistent with 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: 6950746
• Report Number: 1030489-2017-02199
• Device Sequence Number: 16396681
• Product Code: NKB
• UDI-Device Identifier: 00613994579607
• UDI-Public: 00613994579607
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K091974
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/24/2018

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: 54840006550
• Device Lot Number: H5243977
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2018
• Initial Date Received by Manufacturer: 09/28/2017
• Supplement Date Received by Manufacturer: 01/12/2018; 05/22/2018
• Initial Report FDA Received Date: 10/16/2017
• Supplement Report FDA Received Date: 01/23/2018; 05/24/2018
• 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: 33 YR