MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG CD HORIZON SPINAL SYSTEM

Catalog Number 55840006550

Device Problem Mechanical Problem (1384)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

Product analysis: visual and optical inspection revealed the top portion of the crown of the screw has been worn from the seating of the rod.Functional inspection confirmed the screw head was locked in an angled position and was not able to pivot in any direction.The crown has been pushed down through the saddle of the screw not allowing the head to pivot anymore.This is the normal issue when the bone screw is implanted.The screw appears to function as intended.No fault found.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that on (b)(6) 2019, the patient underwent fusion at t11-ilium.Post-op, on (b)(6) 2019, the patient presented with acute pain and infection; hence, the wound was cleaned as the patient got klebsiella.No implant or instrumentation was removed in this surgery.Later, the patient again presented with pain; and underwent a revision surgery on (b)(6) 2019.Allegedly, the tulip of the reported screw was found locked at an angle.In this revision surgery, all the implants were removed and changed as the patient had enterococcus; and the fusion was extended from t11-ilium to t11-s2.

• Brand Name: CD HORIZON SPINAL SYSTEM
• Manufacturer (Section D): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• Manufacturer (Section G): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• Manufacturer Contact: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 9794814
• MDR Text Key: 188487288
• Report Number: 1030489-2020-00265
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00613994971760
• UDI-Public: 00613994971760
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K113174
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 55840006550
• Device Lot Number: H5497329
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Weight: 83