MAUDE Adverse Event Report: NEWDEAL SAS XXX-IPP-ON IMPLANT; N/A

Catalog Number XXX-IPP-ON IMPLANT

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Pain (1994)

Event Date 10/07/2015

Event Type  Injury  

Event Description

It was reported there was loosening of the implant, pain, and metallosis.Action taken involved removal of the implant and revision to first metatarsophalangeal fusion with iliac crest bone graft.

Manufacturer Narrative

Integra has completed their internal investigation on 12/07/2015.The investigation included: methods: review of complaints history.Results: a review of the device history record cannot be performed as no product code and manufacturing lot number was provided.Prior to release, following frequency determined by probability law applied to incoming inspection, ipp-on implants are tested for: - visual aspect: finishing.- documentary inspection: delivery note, certificate of compliance for machining and for packaging, sterilization certificate - functional inspection: proximal external diameter, distal external diameter, external shape of the proximal and distal part.External diameter and external sharp of proximal part are checked during incoming inspection.A review of the complaint system was performed.This is the first incident reported about loosening implant after implementation for the past two years.During the same time period, (b)(4) on implants were sold.The complaint rate for this kind of incident during the stated time period is 0.03 percent.Conclusion: given the description of the event and the observations made during the documentary investigation and the lack of returned product or lot number information, the root cause cannot be determined.

• Brand Name: XXX-IPP-ON IMPLANT
• Type of Device: N/A
• Manufacturer (Section D): NEWDEAL SAS; 97 allee alexandre borodine; 97 allee alexandre borodine; saint priest 69800 ; FR 69800
• Manufacturer (Section G): NEWDEAL SAS; 97 allee alexandre borodine; parc tech de laporte des alpes; saint priest 69800 ; FR 69800
• Manufacturer Contact: maria leonard ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 5213323
• MDR Text Key: 30854277
• Report Number: 9615741-2015-00054
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• PMA/PMN Number: K103623
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: XXX-IPP-ON IMPLANT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/13/2015
• Initial Date FDA Received: 11/10/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/31/2015
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention