MAUDE Adverse Event Report: PEEK ROD IMPLANT; PEED ROD IMPLANT

Device Problems Device Expiration Issue (1216); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/03/2017

Event Type  Injury  

Event Description

I had a lumbar fusion of l4 l5 at (b)(6) hospital centra care on (b)(6) 2017.The surgeon said the peek rod implant expired (b)(6) 2017 he obviously did not examine the package for sterilization if they didn't notice the expiration date.I was told not to worry about it.I am very concerned about the effectiveness and possible risks or side effects of having an expired peek rod placed in spine or if surgery should be redone? my first post op.Check is not until (b)(6).

• Brand Name: PEEK ROD IMPLANT
• Type of Device: PEED ROD IMPLANT
• MDR Report Key: 6529715
• MDR Text Key: 74110551
• Report Number: MW5069402
• Device Sequence Number: 1
• Product Code: KWP
• 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: 04/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/01/2017
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: FLONASE.; MULTI VITAMIN.; NEXIUM; NORCO PRN. JUST SINCE SURGERY; OTC MEDS: CALCIUM WITH VITAMIN D; RXMEDS: LEXAPRO; TYLENOL; VALIUM AT HS
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR
• Patient Weight: 59