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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
Model Number 3100-0030
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Swelling/ Edema (4577)
Event Date 12/30/2020
Event Type  malfunction  
Manufacturer Narrative
The surgeon reports removal of the minibunion device approximately 2 months post-operatively. The (b)(6) female initially underwent double osteotomy and hallux valgus correction with placement of minibunion for hallux valgus and a staple at the akin osteotomy. Additionally, soft tissue anchors were placed across the dip and pop joints of the 2nd and 3rd toe. The patient presented with swelling, redness, and superficial drainage after oral antibiotics. The plate and screws (minibunion) were removed. The motoclip remains implanted. The surgeon notes that the 1st metatarsal was stable. No additional hardware was placed in the 1st metatarsal. Swelling and irritation resolved after hardware removal. No non-conformances were identified in review of manufacturing records. Minibunion screws were removed in addition to the plate: ref: 3100-0030 ln: 501230 qty: 1 product name: minibunion offset. Ref: 3100-3022lk ln: 501197 qty: 1 product name: 3. 0mm x 22mm locking screw. Ref: 3100-2714nl ln: 501199 qty: 1 product name: 2. 7mm x 14mm non-locking screw.
 
Event Description
The surgeon reports removal of the minibunion device approximately 2 months post-operatively. The (b)(6) female initially underwent double osteotomy and hallux valgus correction with placement of minibunion for hallux valgus and a staple at the akin osteotomy. Additionally, soft tissue anchors were placed across the dip and pop joints of the 2nd and 3rd toe. The patient presented with swelling, redness, and superficial drainage after oral antibiotics. The plate and screws (minibunion) were removed. The motoclip remains implanted. The surgeon notes that the 1st metatarsal was stable. No additional hardware was placed in the 1st metatarsal.
 
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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 Key11730323
MDR Text Key280470315
Report Number3011421599-2021-00008
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 health professional
Type of Report Initial
Report Date 04/26/2021
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
Device Expiration Date04/05/2021
Device Model Number3100-0030
Device Catalogue Number3100-0030
Device Lot Number501230
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/23/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/04/2020
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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