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

Catalog Number 54740006545

Device Problems Migration or Expulsion of Device (1395); Malposition of Device (2616)

Patient Problem No Code Available (3191)

Event Date 02/17/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that, patient underwent posterior lumbar inter-body fusion surgery for isthmic spondylolisthesis at l4-l5.During the surgery, it was found through image that the right screw at l5 was placed "too medially" after insertion of screw so the screw was removed and inserted again.Image found no problem after the re-insertion.Post-op, it was confirmed non smooth movement of legs so the surgical site was checked by ct.It was observed the re-inserted screw has come out on the inside and revision surgery was performed on the same day.The surgeon commented that confirmation in the x-ray was difficult due to patient's bone quality.Surgeon also commented that he should have considered the need to use navigation too in such situation.Product came in contact with the patient.No patient complications were 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): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• Manufacturer Contact: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 5488198
• MDR Text Key: 39933244
• Report Number: 1030489-2016-00639
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 02/17/2016

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
• Device Operator: Health Professional
• Device Catalogue Number: 54740006545
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/17/2016
• Initial Date FDA Received: 03/09/2016
• 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): Required Intervention
• Patient Age: 00069 YR
• Patient Weight: 66