• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

CROSSROADS EXTREMITY SYSTEMS MINIBUNION PLATE, FIXATION, BONE Back to Search Results
Catalog Number 3100-2716NL
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Patient Problem/Medical Problem (2688); Missing Value Reason (3192)
Event Date 08/29/2019
Event Type  Injury  
Manufacturer Narrative

The doctor performed a minibunion surgery on (b)(6) 2019. At 2nd week follow-up the patient was walking, and the incision opened up resulting in wound issues. The doctor washed the incision on (b)(6) 2019 and tightened the non-locking screw. The shaft was packed with cancellous bone chips. The patient was hospitalized for 7 days. Intravenous antibiotics were given for 2 weeks and oral antibiotics for an additional 2 weeks. No evidence of a bone infection was identified. No device defects were identified in the investigation. Potentially, early patient mobility may lead to screw back-out. Component implants used in entire construct: minibunion non-locking screw 2. 7mm x 16mm part number: 3100-2716nl, lot number: 500720. Minibunion 3. 5mm offset plate short part number: 3100-0030, lot number: 500737. Minibunion locking screw 3. 0mm x 18mm part number: 3100-3018lk, lot number: 500727.

 
Event Description

The doctor performed a minibunion surgery on (b)(6) 2019. At 2nd week follow-up the patient was walking, and the incision opened up resulting in wound issues. The doctor washed the incision on (b)(6) 2019 and tightened the non-locking screw. The shaft was packed with cancellous bone chips. The patient was hospitalized for 7 days. Intravenous antibiotics were given for 2 weeks and oral antibiotics for an additional 2 weeks. No evidence of a bone infection was identified.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key9460299
MDR Text Key184812423
Report Number3011421599-2019-00027
Device Sequence Number1
Product Code HRS
Combination Product (Y/N)N
PMA/PMN NumberK190658
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Type of Report Initial
Report Date 09/27/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/12/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Device Catalogue Number3100-2716NL
Device LOT Number500720
Was Device Available For Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/13/2019
Was Device Evaluated By Manufacturer? No
Date Device Manufactured05/17/2019
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: 12/12/2019 Patient Sequence Number: 1
-
-