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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CROSSROADS EXTREMITY SYSTEMS MOTOBAND CP IMPLANT SYSTEM; PLATE, CLIP, SCREWS

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CROSSROADS EXTREMITY SYSTEMS MOTOBAND CP IMPLANT SYSTEM; PLATE, CLIP, SCREWS Back to Search Results
Catalog Number 7118-1818KT
Device Problem Fracture (1260)
Patient Problems Pain (1994); Swelling (2091)
Event Date 02/27/2019
Event Type  Injury  
Manufacturer Narrative
The nitinol clip listed previously was used in conjunction with the implants listed below as a total construct for bone fragment osteotomy fixation and joint arthrodesis.In addition to the pain and swelling from the patient, the nitinol implant and the locking screw listed below experienced mechanical failure at some time post-operation.Component implants used in entire construct: motoband cp - locking screws - 3.0mm x 16mm, catalog#: 1500-3016, lot#: 500079, expiration: 08/01/2022.Motoband cp - non-locking screws - 3.5mm x 22mm, catalog#: 1500-3522, lot#: 101416, expiration: 04/01/2021.Dynaforce motoband max z-beta plate 18mm, catalog#: 7100-zb18, lot#: 500243, expiration: 03/15/2020.
 
Event Description
Lapidus procedure was performed on (b)(6) 2018.In follow-up, doctor reports partial fusion of joint in additional to breakage of the hardware - namely 1 locking screw and 1 leg of a nitinol clip.Patient has post-operation pain and swelling.Revision surgery was performed on (b)(6) 2019 to remove hardware.
 
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Brand Name
MOTOBAND CP IMPLANT SYSTEM
Type of Device
PLATE, CLIP, SCREWS
Manufacturer (Section D)
CROSSROADS EXTREMITY SYSTEMS
6055 primacy parkway suite 140
memphis TN 38119
Manufacturer Contact
vernon hartdegen
6055 primacy parkway
suite 140
memphis, TN 38119
9012218406
MDR Report Key8458320
MDR Text Key140119370
Report Number3011421599-2019-00001
Device Sequence Number1
Product Code HRS
UDI-Device Identifier00815432023288
UDI-Public00815432023288
Combination Product (y/n)N
PMA/PMN Number
K173710
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial
Report Date 03/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/05/2020
Device Catalogue Number7118-1818KT
Device Lot Number103010
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/05/2019
Initial Date Manufacturer Received 02/26/2019
Initial Date FDA Received03/27/2019
Was Device Evaluated by Manufacturer? No
Date Device Manufactured04/12/2018
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 Age65 YR
Patient Weight72
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