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

Catalog Number	7577550
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/27/2019
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 single-level spinal surgery due to spondylolisthesis with stenosis.Post-op, the implanted pedicle screw was broken.On (b)(6) 2019, the patient had underwent revision surgery due to an infection.At this revision, the surgeon implanted two new rods and needed four break-off items.The pedicle screws remained in the patient.On (b)(6) 2019, the patient got the second revision due to the sustained infection of the patient.When the surgeon implanted the cage from ventral to check the position with x-ray he remarked the broken pedicle screw.They rotate the patient in this session and replaced the legacy screws.
Additional Manufacturer Narrative
Product analysis results: visual and microscopic inspection confirmed the bone screw disassembled from the head.The ring and crown were still assembled in the head.The retaining ring is fully seated, but has been bent/deformed on one side and the other has been partially sheared off.The deformed and sheared areas are on either side of the retaining ring gap, would reduce the force required for ring failure.Bone screw head diameter found to be within print specification.The above observations are consistent with overload as the mechanism of failure.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Radiographic image review result: intra-op film from anterior revision surgery levels unknown.One of the posterior screws shows the tulip of the screw shaft which required a posterior revision.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: 8829846
• Report Number: 1030489-2019-00817
• Device Sequence Number: 2877019
• Product Code: KWP
• UDI-Device Identifier: 00885074032115
• UDI-Public: 00885074032115
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K032265
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/24/2019

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: 7577550
• Device Lot Number: H5528310
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2019
• Initial Date Received by Manufacturer: 07/01/2019
• Supplement Date Received by Manufacturer: 08/05/2019; 10/02/2019
• Initial Report FDA Received Date: 07/26/2019
• Supplement Report FDA Received Date: 09/03/2019; 10/24/2019
• 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 Age: 70 YR
• Patient Weight: 90