MAUDE Adverse Event Report: DEPUY SYNTHES SPINE UNKNOWN EXPEDIUM IMPLANT

Catalog Number UNKNOWN

Device Problem Insufficient Information (3190)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Product information not available.A complaint investigation will be performed.The complaint product is not available for the investigation.A supplemental report is not anticipated unless the results of the complaint investigation identify a corrective action or additional relevant information.Should the product become available, a physical evaluation will be conducted and a supplemental report filed with the results.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

A new linkedin connection messaged me on (b)(6) 2017 stating he knew two people that worked for depuy spine.He then stated that he "just had two surgeries last year to remove the hardware from my spine.Muscles rubbing over the hardware was causing inflammation and chronic pain.Doing much better now! the hardware was all j&j, viper and expedium.I kept it all, thinking of making something with it." (b)(6) on (b)(6) 2017 email from patient: after receiving fusions in upper levels, it was determined by 2nd opinion that my chronic pain was attributed to muscles rubbing over the hardware causing inflammation.I had two surgeries to remove the hardware from t3-s1 in 2016 ((b)(6)).The chronic pain, just from walking, went away.I do still have constant/chronic pain depending on activity level, but reduced.

• Brand Name: UNKNOWN EXPEDIUM IMPLANT
• Type of Device: UNKNOWN
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): MEDOS INTERNATIONAL SARL; 325 paramount drive; le locle CH-24 00; SZ CH-2400
• Manufacturer Contact: jason busch ; 325 paramount drive; raynham, MA 02767 ; 5088808201
• MDR Report Key: 6644975
• MDR Text Key: 77704757
• Report Number: 1526439-2017-10455
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention