MAUDE Adverse Event Report: DEPUY SYNTHES SKYLINE PLATE AND SCREW

Model Number 1 LEVEL,14MM TI,186801014 SCREW #186850014

Device Problems Loss of or Failure to Bond (1068); Loose or Intermittent Connection (1371); Device Slipped (1584); Sticking (1597); Unstable (1667)

Patient Problems Patient Problem/Medical Problem (2688); No Code Available (3191)

Event Date 04/06/2016

Event Type  Injury  

Event Description

I was implanted with stryker spine aero-c which stuck out 3mm into my esophagus causing damage to it unable to eat caused a revision surgery.Reference report numbers mw5071558,mw5072144, and mw5072144-1.

Event Description

Add'l info received from reporter on 07/30/2018 for report number mw5073583.Reporter stated she was implanted on (b)(6) 2017 with two devices by depuy / synthes; a rod model #04614730, 30mm and a skyline plate 1 level, 14mm, ti, #186801014 with screw # 186850014.Right after the implants, she started to experience pain.She called the mfr to report the incidence and was told that a report will be filed to fda on her behalf and she never heard from them again.Since the implants she's been trying to find help from drs and nobody will help.In (b)(6) 2018 she had a cat scan which shows that the screws in her neck are loose and popped out and are no longer secured.During the same scan, the images also shows that her vertebral had fractured and the screws are the cause.She was advised by a dr to do something because the fracture can lead to paralysis.It was also observed that the bones never fused together.She said she's been going from one problem to another and has no help to solve any of them.Now she is been forced to go to (b)(6) for further consultation.Ref report numbers: mw5071558, mw5072144, and mw5072144-1.

• Brand Name: SKYLINE PLATE AND SCREW
• Type of Device: SKYLINE PLATE AND SCREW
• Manufacturer (Section D): DEPUY SYNTHES
• MDR Report Key: 7063448
• MDR Text Key: 93206599
• Report Number: MW5073583
• Device Sequence Number: 0
• Product Code: KWQ
• Combination Product (y/n): N
• 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: 07/30/2018
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 1 LEVEL,14MM TI,186801014 SCREW #186850014
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 0
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 37 YR
• Patient Weight: 65