MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORP CAGE SUSTAIN O 12 X 10 X 22

Model Number 304.092

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Pain (1994); Rash (2033); Test Result (2695)

Event Date 02/11/2014

Event Type  Injury  

Event Description

(b)(6) 2014 was the date of the spine surgery.Since the surgery my pain worsened.I started getting rashes in 2017, i was tested for the (peek cage), i tested positive.Lumbar decompression fusion l5-s1 with instrumentation (peek cage implant).Date of use: (b)(6) 2014.Did the problem return if the person started taking or using the product again: no.

• Brand Name: CAGE SUSTAIN O 12 X 10 X 22
• Type of Device: CAGE SUSTAIN O 12 X 10 X 22
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORP
• MDR Report Key: 7299609
• MDR Text Key: 101231208
• Report Number: MW5075538
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 304.092
• Device Catalogue Number: 304.092
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 31 YR
• Patient Weight: 96