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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX, INC. ANKLE FUSION PLATE, LATERAL TTC PLATE, FIXATION, BONE

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ARTHREX, INC. ANKLE FUSION PLATE, LATERAL TTC PLATE, FIXATION, BONE Back to Search Results
Model Number ANKLE FUSION PLATE, LATERAL TTC
Device Problem Break (1069)
Patient Problems Failure of Implant (1924); Pain (1994); Swelling (2091)
Event Date 07/10/2020
Event Type  Injury  
Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation. The root cause of the event could not be determined from the information available and without device evaluation.
 
Event Description
It was reported the patient had an ankle fusion on (b)(6) 2019 and the patient experienced pain and swelling had a follow up x-ray at the end of (b)(6) that revealed the ar-8970ttc, ankle fusion plate, was broken. Lot number of the plate was unknown at the time of initial report. The patient had to wait until june to have a revision surgery to remove the broken plate and screws. The doctor used a revision ankle subtalar fusion to remedy the situation. The patient is currently in a cast and in a healing state. Additional information obtained 7/20/2020: the original procedure was a ttc fusion on (b)(6) 2019. The revision surgery took place on (b)(6) 2020. The revision was completed using a nail. The surgeon has the plate and screws and will return them to arthrex for evaluation. The patient suffered no known trauma since the original procedure. Both original and revision procedures were performed by the same surgeon at the same facility. Screw part numbers are not known at this time. Additional information obtained 7/21/2020: the following are the devices originally implanted (b)(6) 2019. The surgeon chose to remove all of the below devices during the revision surgery: ar-8970ttc, ankle fusion plate lateral, lot 6791444. Ar-8545-40, low profile screw, lot 10184335. Ar-8545-44, low profile screw, lot 10265231. Ar-8545l-24, low profile locking screw, lot 1050683. Ar-8545l-28, low profile locking screw, lot 1042333. Ar-8545l-30, low profile locking screw, lot 1051302. Ar-8545l-32, low profile locking screw, lot 1014160. Ar-8545l-38, low profile locking screw, lot 1050682. Ar-8967-1840, low profile screw, lot 031739. Ar-8970-09, large bb-tak, lot 819784873. Ar-8970-09, large bb-tak, lot 900849548. Ar-8970-09t, large bb-tak threaded, lot 021443.
 
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Brand NameANKLE FUSION PLATE, LATERAL TTC
Type of DevicePLATE, FIXATION, BONE
Manufacturer (Section D)
ARTHREX, INC.
1370 creekside boulevard
naples FL 34108 1945
Manufacturer (Section G)
ARTHREX, INC.
1370 creekside boulevard
naples FL 34108 1945
Manufacturer Contact
vik bajnath
8009337001
MDR Report Key10309706
MDR Text Key200454197
Report Number1220246-2020-01969
Device Sequence Number1
Product Code HRS
UDI-Device Identifier00888867134010
UDI-Public00888867134010
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K141735
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/22/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberANKLE FUSION PLATE, LATERAL TTC
Device Catalogue NumberAR-8970TTC
Device Lot Number6791444
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer11/05/2014
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/10/2020
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 Treatment Data
Date Received: 07/22/2020 Patient Sequence Number: 1
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