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

Catalog Number 7078396

Device Problems Break (1069); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Code Available (3191)

Event Date 06/17/2015

Event Type  Injury  

Event Description

Patient demographics: gender:female event date: (b)(6) 2015 procedure: anterior/posterior lumbar fusion initial diagnosis: lumber kyphosis it was reported that a patient underwent an anterior/posterior lumbar fusion surgery at l1-s2ai on (b)(6) 2015.The surgeon was aware of forgetting a final tightening of a set screw by set screw count after post-op x-ray photography.The patient already was extubated and surgical site was closed.After the consent of patient family, the surgeon re-opens the surgical site under general anesthesia and break-off a remained set screw.The surgical time was extended between 31-60 min as a result of the event.Patient complications were reported unknown.

Manufacturer Narrative

(b)(6).

• Brand Name: CD HORIZON SPINAL SYSTEM
• Type of Device: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• 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: 4911194
• MDR Text Key: 6026025
• Report Number: 1030489-2015-01440
• Device Sequence Number: 1
• Product Code: KWP
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 7078396
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/17/2015
• 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