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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NEWDEAL SAS PANTANAIL DEVICE - UNSPECIFIED PANTA NAIL

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NEWDEAL SAS PANTANAIL DEVICE - UNSPECIFIED PANTA NAIL Back to Search Results
Catalog Number XXX-PANTA NAIL
Device Problems Device Operates Differently Than Expected (2913); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Injury (2348)
Event Type  Injury  
Manufacturer Narrative
The device involved in the reported incident is not available for evaluation. An investigation has been initiated based on the reported information. Linked to mfg report number: 9615741-2018-00063, 9615741-2018-00064, 9615741-2018-00065, 9615741-2018-00066.
 
Event Description
The bone and joint journal (2018) published: "mid-term follow-up of patients with hindfoot arthrodesis with retrograde compression intramedullary nail in charcot neuropathy of the hindfoot". The purpose of this study is to evaluate the mid-term outcome of hindfoot reconstruction in terms of union, function, alignment, and complication rate in patients with deformity of the ankle secondary to charcot arthropathy presenting with or without ulcers, with the major endpoint being the rate of limb salvage. A total of 18 patients (19 feet) with an advanced degree of ankle and subtalar joint instability and/or deformity were operated on during the study period (january 2011 to june 2013). In three limbs, amputation had to be performed due to persisting infection and osteomyelitis resistant to parenteral antibiotic therapy and repeated debridement. All amputees were initially poor hosts in terms of general health and immunity status. All of them had preoperatively presented with infected sole ulceration. Two of them were diabetic patients and one was a heavy smoker with established peripheral vascular disease. Additional information has been requested to the author.
 
Manufacturer Narrative
Integra has completed their internal investigation: as no product id and no manufacturing lot number was provided to integra, no dhr, design specification or design change record will be performed. No failure analysis was performed, product was not returned. The root cause is not determined but, physical condition, preoperative risk factors and etiologies of the patient might be reason of amputation. Indeed, as mentioned in clinical evidence report, comorbidities such as diabetes and charcot arthropathy as well as preoperative ulcers pose a higher risk of amputation.
 
Manufacturer Narrative
Additional information was requested to the author, the following was received:: patient: (b)(6) years old, male. Fusion level: hindfoot and midfoot; left side. Date of initial procedure: (b)(6) 2014. Follow-up: 13 months. The literature reports 3 amputations; however, based on additional information received, intgera panta nail was implanted in 2 of the 3 amputations. A competitor implant was used in the other amputation case. This report is linked to mfg report number: 9615741-2018-00067.
 
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Brand NamePANTANAIL DEVICE - UNSPECIFIED
Type of DevicePANTA NAIL
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
sonia irizarry
311 enterprise drive
plainsboro, NJ 08536
6099362393
MDR Report Key7487844
MDR Text Key107386185
Report Number9615741-2018-00062
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
PMA/PMN Number
K091788
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type literature
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 04/16/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/04/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberXXX-PANTA NAIL
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/23/2018
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 Unkown

Patient Treatment Data
Date Received: 05/04/2018 Patient Sequence Number: 1
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