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

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Perforation (2001); Pressure Sores (2326)

Event Type  Injury  

Manufacturer Narrative

The part# and lot# of the suspect screw was not identified, therefore, the manufacturer cannot determine the suspect device.How ever, the following screws were used in patient: part# 54750015540, lot# h5215320, h5293666, h5341270 and upn# (b)(4).Part# 54750015545, lot# h5179064, h5179246, h5329590 and upn# (b)(4).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 a patient with history of multiple bone tumor underwent posterior fixation with postpartum sterilization procedures on two diseased (collapsed) vertebral bodies.Post-op, the screw backed out due to forward or backward flexion of patient and protruded from the skin.Pressure sores attributed to the protrusion of implant from the dorsal.It is planed to remove the screw.

• 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: 7214576
• MDR Text Key: 98043621
• Report Number: 1030489-2018-00105
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K143375
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Service Personnel
• Type of Report: Initial
• Report Date: 01/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/26/2017
• 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: 67 YR