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

Catalog Number 55790014525

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Pain (1994); Pressure Sores (2326); No Code Available (3191)

Event Date 01/01/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Neither the device nor applicable imaging films were returned to manufacturer for evaluation therefore we are unable to determine the definitive cause of event.

Event Description

It was reported that patient underwent with "posterior hypotony" underwent spinal fixation surgery at t2-s2ai on (b)(6) 2016.Post-op, in 2017(date unknown), screw at t2-3 backed out and left rod at cranial side, was stuck out of the patient's skin.Patient underwent revision surgery in which surgeon cut the rod at t3/4 part of it and t2-3 screws were removed.Also x10 cross link placed at t3/4 was removed.Patient has pain and pressure sores.Four screws were explanted at t2/3.Patient symptoms were improved by cutting and removing the rod.The rod still remained inside the patient.After that, the incision was cleaned and closed.

Manufacturer Narrative

Corrected data.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.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: 6359910
• MDR Text Key: 68350857
• Report Number: 1030489-2017-00431
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/07/2017

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: 55790014525
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/02/2017
• Initial Date FDA Received: 02/27/2017
• Supplement Dates Manufacturer Received: 08/07/2017; 08/07/2017
• Supplement Dates FDA Received: 08/11/2017; 09/29/2017
• 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
• Treatment: CROSSLINK, RODS
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR