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

Catalog Number 54740006555

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

Patient Problems Pain (1994); Spinal Column Injury (2081)

Event Type  Injury  

Manufacturer Narrative

Outcomes to adverse events: others: pyogenic spondylitis: this part is not approved for market in the us; however, a like device with part# 54840006555, 510(k): k091974 and upi #: (b)(4) was cleared in the united states.Neither the device nor films of applicable imaging studies were 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 Description

It was reported that on (b)(6) 2019, the patient underwent posterolateral spinal fusion (psf) at l2-l5 and posterior lumbar interbody fusion (plif) at l3-l5.On an unknown date, post-op, patient suffered with pain in the lower back and pyogenic spondylitis was reported at l5.The screws implanted on both sides of l5 loosened.Hence, on (b)(6) 2019, the patient underwent a revision surgery; in which, the rod along with the loosened screws at l5 were removed.Additional screw insertion was performed at s1 and s2ai, and fixation range was extended.Currently, the patient is in bad condition and is in icu.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• 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: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 9122840
• MDR Text Key: 161078149
• Report Number: 1030489-2019-01072
• 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,Followup
• Report Date: 09/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 54740006555
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/27/2019
• Was Device Evaluated by Manufacturer?: No
• 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): Hospitalization; Life Threatening; Other; Required Intervention