MAUDE Adverse Event Report: NUVASIVE SPECIALIZED ORTHOPEDICS, INC. PRECICE SYSTEM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Wound Dehiscence (1154); Hematoma (1884); Hemorrhage/Bleeding (1888)

Event Date 04/10/2021

Event Type  Injury  

Manufacturer Narrative

Device has not been returned for evaluation as it remains in-situ and no event information provided indicates a cause of the reported event.The item lot number was also not provided and therefore a review of manufacturing records could not be performed.The root cause is unable to be determined at this time.Labeling review: ".There is a possibility of nerve or soft tissue damage and/or weakness related to either surgical trauma or the presence of the implant." if any additional information is provided a supplemental report will be submitted.

Event Description

Information was received that subsequent to a nail replacement procedure, the patient experienced bleeding from the surgical wound.Examination of the surgical wound found a hematoma in the wound cavity and dehiscence.Wound irrigation and debridement was performed to address the patient issue.No further patient adverse impact was reported and the nail remains in-situ.No additional information is available.

• Brand Name: PRECICE SYSTEM
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise dr ste 100; aliso viejo CA 92656
• Manufacturer (Section G): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise dr ste 100; aliso viejo CA 92656
• Manufacturer Contact: geoff gannon ; 101 enterprise dr ste 100; aliso viejo, CA 92656 ; 8583448112
• MDR Report Key: 13984380
• MDR Text Key: 291635495
• Report Number: 3006179046-2022-00165
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K191336
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/21/2022
• 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 Number: 1
• Patient Outcome(s): Other; Hospitalization
• Patient Sex: Male