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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS, INC. MGT MOVEMENT PROX PHAL TOTAL SZ 20; MOVEMENT GREAT TOE

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ASCENSION ORTHOPEDICS, INC. MGT MOVEMENT PROX PHAL TOTAL SZ 20; MOVEMENT GREAT TOE Back to Search Results
Catalog Number MGT-890-20PPT
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fatigue (1849); Headache (1880); Hypersensitivity/Allergic reaction (1907); Pain (1994); Swelling (2091); Malaise (2359)
Event Type  Injury  
Event Description
It was reported the pt was complaining of systemic problems and believes her fatigue, malaise and hypersensitivity over her entire body are due to the metal in the device implant placed in her great toe on (b)(6) 2014.It was reported the surgeon is looking for info of history of other similar cases, evidence the device does not cause these issues and agreement/confirmation that an allergic reaction would be localized to the great toe area.Add'l info has been requested.Add'l info rec'd 5feb2015: rec'd a phone call from the reporter of the complaint.She and the physician believe the pt thinks her toe implant will have similar problems as metal-to-metal hip implants.She wants to explore if there are metal ions in her blood stream causing systemic problems.The physician is sending the pt for a second opinion and recommended she go for environmental testing.(b)(4) wants to know when the (b)(4) conversation with dr.(b)(6) occurs.Device remains implanted.More add'l info rec'd via email 5feb15: i just heard back from the physician.He stated that the pt has been diagnosed with idiopathic environmental intolerance (aka multiple chemical sensitivity); this is new since surgery.She is unable to work and now has a new sensitivity to fragrances and headaches- this is what she is calling whole body allergic reaction.She is also having typical pain, stiffness adn swelling in the joint.She is being referred to another physician who uses these implants.
 
Manufacturer Narrative
The device will not be returned since it remains implanted.Based on reported info, integra has initiated an investigation.
 
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Brand Name
MGT MOVEMENT PROX PHAL TOTAL SZ 20
Type of Device
MOVEMENT GREAT TOE
Manufacturer (Section D)
ASCENSION ORTHOPEDICS, INC.
austin TX
Manufacturer Contact
maria leonard
311 enterprise dr
plainsboro, NJ 08536
6099362341
MDR Report Key4510153
MDR Text Key21726806
Report Number1651501-2015-00003
Device Sequence Number1
Product Code LZJ
Combination Product (y/n)N
PMA/PMN Number
K102549
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 01/15/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberMGT-890-20PPT
Device Lot Number13-1798
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/15/2015
Initial Date FDA Received02/10/2015
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 Initial
Patient Sequence Number1
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