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

Model Number 54740008550

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

Health damage in patient; lower limb symptoms.Report source: foreign: (b)(6); similar devices 510(k) #: k201407, k202328, k201362.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from healthcare professional via manufacturing representative regarding patient with stenosis on l5 suggested for spinal therapy.Event occurred during use of the implant.Plif was performed on l2-5 on (b)(6) 2012.On (b)(6) 2014, implant on l2-5 was removed and fusion was performed on t12-l5.On (b)(6) 2014, fusion was extended to 9-10-11.On (b)(6) 2017, implant on t9, 10, 11 was removed and fusion was extended to t6-7-8.It was reported that there was lower limbs symptom occurred on l5.Revision surgery was performed.Plif was performed on l5-s1.Implant remains in patient.Health damage in patient reported.No further symptoms or complications reported.

• Brand Name: CD HORIZON SPINAL SYSTEM
• Type of Device: 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
• Manufacturer (Section G): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• Manufacturer Contact: tricha miles ; 1800 pyramid place; memphis, TN 38132 ; 7635140379
• MDR Report Key: 10739004
• MDR Text Key: 213189588
• Report Number: 1030489-2020-01488
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: SEE H10
• 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: 10/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/27/2019
• Device Model Number: 54740008550
• Device Catalogue Number: 54740008550
• Device Lot Number: H11H4052
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/12/2020
• 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): Other; Required Intervention
• Patient Age: 87 YR