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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 15LP-3536
Device Problems Appropriate Term/Code Not Available (3191); Migration (4003)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/14/2021
Event Type  malfunction  
Manufacturer Narrative
The dynabunion system with anti-drift bolt was implanted (b)(6) 2021.Approximately 3 months later after routine follow-up, the sales representative reported that the anti-drift bolt backed out.The representative did not report that the abd was removed.The representative did not report that the patient had clinical symptoms such as pain associated with the anti-drift bolt back-out.Non-conformance was not identified based on the lots that would contribute to this failure mode.Potentially, force from weight-bearing with normal walking motion caused the screw to back-out.Screw back-out is a known failure mode of screws.The following devices were implanted with the anti-drift bolt: ref: 15nl-3018, ln: 400040, qty: 2, product name: motoband cp, non-locking screw, 3mm x 18mm.Ref: 15nl-3018, ln: 400091, qty: 1, product name: motoband cp, non-locking screw, 3mm x 18mm.Ref: 7118-1818, ln: 501371, qty: 1, product name: implant single pack, dynaforce himax, 18 x 18 x 18.Ref: 7100-lp18-r, ln: 501290, qty: 1, product name: dynabunion plate right 18mm.
 
Event Description
The dynabunion system with anti-drift bolt was implanted (b)(6) 2021.Approximately 3 months later after routine follow-up, the sales representative reported that the anti-drift bolt backed out.The representative did not report that the abd was removed.The representative did not report that the patient had clinical symptoms such as pain associated with the anti-drift bolt back-out.
 
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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 Key15501551
MDR Text Key306319013
Report Number3020584246-2022-00055
Device Sequence Number1
Product Code HRS
UDI-Device Identifier00815432028825
UDI-Public00815432028825
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 Other
Type of Report Initial
Report Date 09/28/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/29/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number15LP-3536
Device Catalogue Number501187
Was Device Available for Evaluation? No
Date Manufacturer Received07/14/2021
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 Sequence Number1
Patient Outcome(s) Other; Required Intervention;
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