MAUDE Adverse Event Report: STRYKER PEEK IMPLANT

Model Number ANCHOR C

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Deposits (1809); Foreign Body Reaction (1868); Inflammation (1932); Pain (1994); Scarring (2061); Inadequate Osseointegration (2646); Fibrosis (3167)

Event Date 09/12/2017

Event Type  Injury  

Event Description

Failed fusion, no bone growth, and body attacking the implant device peek.Replaced stryker device with skyline anterior cervical plate, posterior rods and screws.Reference voluntary report numbers mw5071558, mw5073583 and mw5073583-1.

Event Description

Add'l info received from reporter on 09/13/2017 for report # mw5072144.Reporter believes she may have reacted to the plastic in the device; however, it was not confirmed due to a failed allergy test.She states she has suffered from a damaged esophagus caused by multiple revised surgeries.Also, has developed scar tissue and inflammation and will never be pain-free.Her doctor reported results of adherent fibrous tissue with reactive bone, hemosiderin deposition.Reference voluntary report numbers mw5071558, mw5073583 and mw5073583-1.

• Brand Name: PEEK IMPLANT
• Type of Device: PEEK IMPLANT
• Manufacturer (Section D): STRYKER
• MDR Report Key: 6864759
• MDR Text Key: 86277638
• Report Number: MW5072144
• Device Sequence Number: 3
• Product Code: MBI
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 10/02/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2017
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: ANCHOR C
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 37 YR
• Patient Weight: 64