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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS SALTO TALARIS IMPLANT - UNSPECIFIED; ANKLE REPLACEMENT

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ASCENSION ORTHOPEDICS SALTO TALARIS IMPLANT - UNSPECIFIED; ANKLE REPLACEMENT Back to Search Results
Catalog Number XXX-SALTO TALARIS IMPLANT
Device Problems Device Operates Differently Than Expected (2913); Material Deformation (2976)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)
Event Type  malfunction  
Manufacturer Narrative
The device involved in the reported incident is not available for evaluation.An investigation has been initiated based on the reported information.
 
Event Description
It was reported a general complaint by the surgeon who noticed limited bony ingrowth on the implant¿s coated surface, when doing revision cases of salto talaris ankle replacements over a course of a couple of years.He also noted that the coating¿s roughness changed when going to a new coating vendor (b)(4) approximately 5 years ago, and contributes this change to the cause of limited bony ingrowth.In his estimations that normal bony ingrowth covers about 50% of the coated surface, but only saw about 10% coverage with the new vendor.
 
Manufacturer Narrative
Integra has completed their internal investigation on september 28, 2017.Results: dhr review; a review of the lot record was not conducted, as the complaint was general in nature.No specific part number or lot number was identified.Complaints history; a review of the complaint records for the same product for the alleged hazardous situation/failure mode (bone failed to ¿ongrow¿) showed twelve complaints for this implant system having been received.Number of procedure = 1074 procedures as of (b)(6) 2017.Complaint rate = 12/1074*100 = 1.12%.Conclusion: as no implants were returned for investigation and due to the complaint¿s general nature, a possible root cause could not be found from the information provided.
 
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Brand Name
SALTO TALARIS IMPLANT - UNSPECIFIED
Type of Device
ANKLE REPLACEMENT
Manufacturer (Section D)
ASCENSION ORTHOPEDICS
8700 cameron road #100
8700 cameron road #100
austin TX 78754
Manufacturer (Section G)
ASCENSION ORTHOPEDICS
8700 cameron road #100
austin TX 78754
Manufacturer Contact
sonia irizarry
311 enterprise drive
plainsboro, NJ 08536
6099362393
MDR Report Key6875091
MDR Text Key87742007
Report Number1651501-2017-00038
Device Sequence Number1
Product Code HSN
Combination Product (y/n)N
PMA/PMN Number
K060544
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 08/25/2017
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? Yes
Device Operator Health Professional
Device Catalogue NumberXXX-SALTO TALARIS IMPLANT
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 08/25/2017
Initial Date FDA Received09/19/2017
Supplement Dates Manufacturer Received09/28/2017
Supplement Dates FDA Received09/29/2017
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 Unknown
Patient Sequence Number1
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