MAUDE Adverse Event Report: DEPUY/SYNTYHES WS EXP SI POLYAXIAL SCREW 6 X 55 MM SYNTHES 1-79712655; PEDICLE SCREW

Model Number 118952

Device Problem Fracture (1260)

Patient Problem Nerve Damage (1979)

Event Date 04/24/2017

Event Type  Injury  

Event Description

I need your help.Since a defect pedicle screw from the company depuy/synthes with a hairline fracture was implanted into my lumbar spine i am confined to a wheelchair and can no longer work as a medical doctor in my own medical practice.The operation was intended to stabilize my lumbar spine with a spondylodesis using pedicle screws.The manufacturer of these pedicle screw is the company depuy/synthes.Caused permanent nerve damage.One of the implanted pedicle screws (ws exp ti polyaxialschraube 7 x 45 mm synthes serial (b)(4) had a hairline fracture.This crack was confirmed by x-ray and by the operating surgeon by palpation.He could feel the crack as he removed the pedicle screw during the revision surgery.The fact of a hairline fracture is reported in the operation report and in the release report (copies of both are included).I already reported this to the (b)(6) (a copy of this letter and the translation into english is also included).The (b)(6) regulating authority that corresponds to the fda in the usa.Newly occurred knee extensor palsy right on the 3rd postoperative day.Hairline fracture of the pedicel lwk4 right with nerve irritation of the l4 nerve root on the right side intraspinal hematoma l 3/4 extending caudally.Since i can no longer work as a medical doctor in my own medical practice i am losing over one million euros.Without this disability i would have been able to work at least for 10 years.The financial loss is an annual income of (b)(6) over a period of 10 years.My questions concerns product liability.Is not the manufacturer of the defective device that was implanted responsible for this damage? you cannot expect the surgeon to inspect every pedicle screw before surgery with x-ray and ultrasound to rule out hairline fractures and other defects.

• Brand Name: WS EXP SI POLYAXIAL SCREW 6 X 55 MM SYNTHES 1-79712655
• Type of Device: PEDICLE SCREW
• Manufacturer (Section D): DEPUY/SYNTYHES
• MDR Report Key: 7209012
• MDR Text Key: 97986917
• Report Number: MW5074682
• Device Sequence Number: 1
• Product Code: MNI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 118952
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 66 YR