MAUDE Adverse Event Report: MEDTRONICS PEEK PREVAIL CERVICAL INTERBODY IMPLANT; BONE GRAFT

Lot Number PY34

Device Problem Malposition of Device (2616)

Patient Problem No Code Available (3191)

Event Date 01/01/2013

Event Type  Injury  

Event Description

In (b)(6) 2009 i had the peek prevail cervical interbody implant put in at (b)(6) and manufactured by medtronics.I have trouble swallowing.A cat scan showed a screw going into my esophagus.Future surgery will be required to have the screw removed.

• Brand Name: PEEK PREVAIL CERVICAL INTERBODY IMPLANT
• Type of Device: BONE GRAFT
• Manufacturer (Section D): MEDTRONICS
• MDR Report Key: 4774358
• MDR Text Key: 20367373
• Report Number: MW5042718
• Device Sequence Number: 1
• Product Code: ODP
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: PY34
• Patient Sequence Number: 1
• Treatment: AMITRIPTYLIN,; IBUPROFEN,; 2700MG GAPENTIN PER DAY,; OTC MEDS: VITAMINS C, D3, B6 AND B12.; TRAMADOL,; ASPIRIN,; CYCLOBENZAPR,; TIZANIDINE,; METFORMIN,; LISINOPRIL/HYDROCHLORTHIAZIDE,; RX MEDS: DULOXETINE,; BACLOFEN,
• Patient Outcome(s): Other; Disability
• Patient Age: 52 YR
• Patient Weight: 98