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

Catalog Number	55840007545
Health Effect - Clinical Codes	Failure of Implant (1924); Post Operative Wound Infection (2446); Device Embedded In Tissue or Plaque (3165)
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.Pre-op mri and post-op x-rays for l5-s1 fusion shows there is minimal pre-op listhesis and post-op hardware placement appears appropriate.It was difficult to see a broken screw on provided images, but given time for surgery, presumably fusion had not occurred.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient underwent l5-s1 fusion surgery in (b)(6) 2017 for an olisthesis syndrome.Post-op, screw breakage and some cartilage was reported in the wound around l5-s1.The broken, missing front part of the screw was left in the patient.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information: product analysis - visual examination of the mas bone screw confirmed bone screw complete fracture at approximately ~5 threads from the base of the bone screw head.Visual 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 until subsequent mechanical failure of the implant.The above observations are consistent with cyclic fatigue.Due to imdrf harmonization, some previously submitted device, method, result, and conclusion codes related to this event may have been updated 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: 7713214
• Report Number: 1030489-2018-01046
• Device Sequence Number: 903750
• Product Code: KWP
• UDI-Device Identifier: 00643169004344
• UDI-Public: 00643169004344
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K113174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/05/2018

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: 55840007545
• Device Lot Number: H5354825
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2018
• Initial Date Received by Manufacturer: 06/26/2018
• Supplement Date Received by Manufacturer: 08/08/2018; 09/18/2018
• Initial Report FDA Received Date: 07/24/2018
• Supplement Report FDA Received Date: 10/03/2018; 10/05/2018
• 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: Other
• Patient Weight: 60