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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 Loose or Intermittent Connection (1371)
Patient Problems Post Operative Wound Infection (2446); Swelling/ Edema (4577)
Event Date 01/12/2021
Event Type  malfunction  
Manufacturer Narrative
The original bunion correction was performed on (b)(6) 2020 with the crossroads minibunion products. X-ray evidence at 2-weeks post-operation shows the plate not fully seated onto the shaft of the 1st metatarsal and minimal purchase of the non-locking screw into the lateral cortex of the shaft of the 1st metatarsal with the screw head slightly backed out from the plate. According to the surgeon, the patient had severe post-operative swelling, evidence of wound breakdown with infection, and a non-locking screw that backed-out potentially from restless leg syndrome. Non-conformance was not identified based on the lots that would contribute to these events. Screw back-out may have been due to inadequate fixation intra-operatively or due to the restless leg syndrome of the patient. The following screws were removed with the plate: ref: 3100-3024lk ln: 501198 qty: 1 product name: minibunion locking screw 3. 0mm x 24mm. Ref: 3100-2722nl ln: 500723 qty: 1 product name: minibunion non-locking screw 2. 7mm x 22mm.
 
Event Description
The original bunion correction was performed on (b)(6) 2020 with the crossroads minibunion products. X-ray evidence at 2-weeks post-operation shows the plate not fully seated onto the shaft of the 1st metatarsal and minimal purchase of the non-locking screw into the lateral cortex of the shaft of the 1st metatarsal with the screw head slightly backed out from the plate. According to the surgeon, the patient had severe post-operative swelling, evidence of wound breakdown with infection, and a non-locking screw that backed-out potentially from restless leg syndrome.
 
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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 Key11747271
MDR Text Key263590830
Report Number3011421599-2021-00007
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 04/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/29/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
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 Manufactured05/17/2021
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: 04/29/2021 Patient Sequence Number: 1
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