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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CROSSROADS EXTREMITY SYSTEMS MOTOBAND CP IMPLANT SYSTEM; PLATE, FIXATION, BONE
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CROSSROADS EXTREMITY SYSTEMS MOTOBAND CP IMPLANT SYSTEM; PLATE, FIXATION, BONE Back to Search Results
Model Number 7100-LP18-L
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Implant Pain (4561)
Event Date 04/14/2022
Event Type  malfunction  
Event Description
On (b)(6), 2022, the surgeon removed dynabunion implants that were implanted (b)(6), 2021.Implants were removed per patient request due to prominence leading to irritation.Hardware was removed and not replaced.Union was present.
 
Manufacturer Narrative
On (b)(6), 2022, the surgeon removed dynabunion implants that were implanted (b)(6), 2021.Implants were removed per patient request due to prominence leading to irritation.Hardware was removed and not replaced.Union was present.Implants were not returned for analysis.Review of production records did not identify non-conformance for the components removed.In addition to the dynabunion plate, the following screws and staple were removed as part of the overall construct: ref: 15lp-3532 ln: 501185 qty: 1 product name: dynabunion anti-drift bolt, ref: 7118-1818 ln: 501403 qty: 1 product name: himax 18mm x 18mm x 18mm, ref: 1500-3518 ln: 400186 qty: 1 product name: motoband non-locking screw 3.5mm x 18mm, ref: 15pl-3518 ln: 400166 qty: 1 product name: motoband polyaxial locking screw 3.5mm x 18mm, ref: 15pl-3530 ln: 501040 qty: 1 product name: motoband polyaxial locking screw 3.5mm x 30mm.
 
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Brand Name
MOTOBAND CP IMPLANT SYSTEM
Type of Device
PLATE, FIXATION, BONE
Manufacturer (Section D)
CROSSROADS EXTREMITY SYSTEMS
6423 shelby view dr.
suite 101
memphis TN 38134
Manufacturer Contact
6423 shelby view dr.
suite 101
memphis, TN 38134
9012218406
MDR Report Key14478311
MDR Text Key300354162
Report Number3020584246-2022-00002
Device Sequence Number1
Product Code HRS
UDI-Device Identifier00815432028788
UDI-Public00815432028788
Combination Product (y/n)N
PMA/PMN Number
K193452
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Physician
Type of Report Initial
Report Date 05/23/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/23/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number7100-LP18-L
Device Catalogue Number7100-LP18-L
Device Lot Number501444
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/08/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/08/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/27/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age70 YR
Patient SexFemale
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