MAUDE Adverse Event Report: CROSSROADS EXTREMITY SYSTEMS DYNAFORCE MPJ FUSION SYSTEM; BONE PLATE, BONE SCREWS, BONE STAPLE

Model Number	MPJ Short 5deg Valgus/5deg Dorsiflexion
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/28/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The titanium dynaforce mpj plate listed previously was used in conjunction with the implants listed below as a total construct for bone fragment osteotomy fixation and joint arthrodesis.Component implants used in entire construct: motoband cp - locking screw - 3.0mm x 12mm, catalog#: 1500-3012, lot#: 500551, expiration: 01/17/2021.Motoband cp - non-locking screw - 3.0mm x 12mm, catalog#: 15nl-3012, lot#: 500330, expiration: 10/16/2020.Motoband cp - non-locking screw - 3.0mm x 16mm, catalog#: 15nl-3016, lot#: 500454, expiration: 07/11/2020.Motoband cp - non-locking screw - 3.0mm x 16mm, catalog#: 15nl-3016, lot#: 500332, expiration: 07/16/2020.Dynaforce himax implant kit 18x14x14, catalog#: 7119-1414kt, lot#: 300096, expiration: 01/24/2021.
Event or Problem Description
Doctor performed an mpj fusion surgery on (b)(6) 2019.At follow-up visit, patient's surgical site exhibited poor wound healing.Revision surgery took place on (b)(6) 2019 which included debridement of the wound and removal of the hardware including plate, screws, and staple.

• Brand Name: DYNAFORCE MPJ FUSION SYSTEM
• Common Device Name: BONE PLATE, BONE SCREWS, BONE STAPLE
• Manufacturer (Section D): CROSSROADS EXTREMITY SYSTEMS; 6055 primacy parkway; suite 140; memphis TN 38119
• MDR Report Key: 8538183
• Report Number: 3011421599-2019-00002
• Device Sequence Number: 361608
• Product Code: HRS
• UDI-Device Identifier: 00815432026371
• UDI-Public: (01)00815432026371(17)201016(10)500424
• Combination Product (Y/N): N
• PMA/510(K) Number: K160300
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/28/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/16/2020
• Device Model Number: MPJ Short 5deg Valgus/5deg Dorsiflexion
• Device Catalogue Number: 7150-5018
• Device Lot Number: 500424
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2019
• Initial Report FDA Received Date: 04/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention