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

Catalog Number	55840016545
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
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 mis screw instertion procedure at l5-s1 due to degenerative disc disease.Post-op, the screw broke in half.Due to the screw breakage, the patient needed revision surgery less than 12 month since implantation.The tulip head and some part of the screw (implanted at s1 level) have been removed from the patient, the remaining screw has been left in situ.Due to the fact part of the screw remains in the patient it was impossible to replace like for like and therefore the construct needed to be extended - all screws from the first operation were removed and replaced with fenestrated screws.The construct extension was required since the implants were not completely fused.
Additional Manufacturer Narrative
Product analysis result: visual microscopic visual inspection confirmed the bone screw has broken approximately 9 threads from the base of the bone screw head.There are witness marks on the saddle of the bone screw but no indication of the rod was sitting at an off axis angle.Optical examination did not identify material defect near the area of fracture origin, which could contribute to crack propagation.Microscopic examination of the fracture surface identified gently curving convex striations through the cross sectional area of the implant, which are indicative of cyclic fatigue.It appears the repeated force placed on the bone screw caused a cyclic fatigue 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: 8369146
• Report Number: 1030489-2019-00201
• Device Sequence Number: 13717639
• Product Code: KWP
• UDI-Device Identifier: 00643169077423
• UDI-Public: 00643169077423
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K113174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2019

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: 55840016545
• Device Lot Number: H5332252
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2019
• Initial Date Received by Manufacturer: 01/28/2019
• Supplement Date Received by Manufacturer: 04/26/2019
• Initial Report FDA Received Date: 02/26/2019
• Supplement Report FDA Received Date: 04/30/2019
• 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