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

Model Number 75645540

Device Problems Corroded (1131); Material Deformation (2976)

Patient Problems Necrosis (1971); Pain (1994)

Event Date 12/10/2011

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from a patient via regulatory body.It was reported that "in 2011, when patient was fourteen years old, patient had a surgery to correct scoliosis.The surgeon used the medtronic 5.5 mm legacy spinal system, which included 15 screws and two rods.Patient had an extremely difficult stay in the pediatric intensive care unit and was there for almost a week.In the following months, patient healed very slowly.Patient pain levels were unexpectedly high, and patient never fully stopped needing prescription pain medication.Patient¿s pain was getting worse.Blood tests and physical examinations did notreveal anything wrong.Implants caused severe distortion on mri images.Doctor could not get a clear image of the implants because of the implants themselves.Patient had a second surgery to have the implants removed.During surgery it was noticed that patient¿s spine was covered in a grey-green sludge.Laboratory analysis revealed it to be the result of a severe necrotic reaction: the stainless steel had irritated patients¿ insides, flesh had died and liquefied.The surgeon carved out rotting muscle, fascia, and bone.The implants came out crooked and corroded.The patient felt better two weeks after the surgery.Patient was still physically disabled with some chronic pain and fatigue and had a lower quality of life.Patient had to use pain medications regularly and sometimes needed a wheelchair.Concomitant medical buprenorphine 8 mg 3,5 x daily for chronic pain, effexor 87.5 mg for depression secondary to chronic pain, alprazolam 1 mg 1x weekly for muscle spasms, aleve 200mg".

• Brand Name: CD HORIZON
• 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): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• Manufacturer Contact: glen belmer ; 1800 pyramid place; memphis, TN 38132 ; 6122713209
• MDR Report Key: 12726302
• MDR Text Key: 279274112
• Report Number: 1030489-2021-01329
• Device Sequence Number: 1
• Product Code: KWP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 75645540
• Device Catalogue Number: 75645540
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/06/2021
• 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