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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CROSSROADS EXTREMITY SYSTEMS MINIBUNION PLATE, FIXATION, BONE

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CROSSROADS EXTREMITY SYSTEMS MINIBUNION PLATE, FIXATION, BONE Back to Search Results
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Post Operative Wound Infection (2446); Swelling/ Edema (4577)
Event Date 12/04/2020
Event Type  malfunction  
Manufacturer Narrative
The distributor communicated that dr. (b)(6) had 3 potential infections occurred with minibunion usage. The surgeon confirmed that one of cases performed on (b)(6) 2020 experienced delayed healing, edema and took oral antibiotics. Two (2) case reports are from (b)(6) 2020 as it is unclear which case experienced this event. The surgeon expressed that during the procedure control of the capital fragment was difficult and the bone cortex may not have been smooth causing soft tissue irritation as there is not a lot of tissue over the surgical site. The hardware was not removed, and healing occurred approximately 6 weeks post-operatively. The part number and lot number associated with the event is unknown. The surgeon performed 4 cases; 3 cases included a single lot. Part number 3100-2716nl lot 510023 with available parts. Cytotoxicity, endotoxin and bioburden testing was performed and met acceptance criteria.
 
Event Description
The distributor communicated that dr. (b)(6) had 3 potential infections occurred with minibunion usage. The surgeon confirmed that one of cases performed on (b)(6) 2020 experienced delayed healing, edema and took oral antibiotics. Two (2) case reports are from (b)(6) 2020 as it is unclear which case experienced this event. The surgeon expressed that during the procedure control of the capital fragment was difficult and the bone cortex may not have been smooth causing soft tissue irritation as there is not a lot of tissue over the surgical site. The hardware was not removed, and healing occurred approximately 6 weeks post-operatively.
 
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Brand NameMINIBUNION
Type of DevicePLATE, FIXATION, BONE
Manufacturer (Section D)
CROSSROADS EXTREMITY SYSTEMS
6055 primacy parkway ste 140
memphis TN 38119
Manufacturer Contact
6055 primacy parkway ste 140
memphis, TN 38119
9012218406
MDR Report Key11730330
MDR Text Key280469896
Report Number3011421599-2021-00003
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
PMA/PMN Number
K190658
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial
Report Date 03/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/27/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/22/2021
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: 04/27/2021 Patient Sequence Number: 1
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