FDA Adverse Event Injury Summary report: N

DYNAFORCE MPJ FUSION SYSTEM

MDR report key: 8538183 · Received April 22, 2019

Report

Report Number: 3011421599-2019-00002
Event Type: Injury
Date Received: April 22, 2019
Date of Event: March 28, 2019
Report Date: March 28, 2019
Manufacturer: CROSSROADS EXTREMITY SYSTEMS
Product Code: HRS
UDI-DI: 00815432026371
PMA / PMN Number: K160300
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

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.

Description of Event or Problem · 1

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.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
330205	DYNAFORCE MPJ FUSION SYSTEM	BONE PLATE, BONE SCREWS, BONE STAPLE	HRS	CROSSROADS EXTREMITY SYSTEMS	MPJ Short 5deg Valgus/5deg Dorsiflexion	500424	00815432026371

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention