MAUDE Adverse Event Report: NUVASIVE SPECIALIZED ORTHOPEDICS, INC. PRECICE PLATING SYSTEM; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Model Number LP4.5-MLT4B

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

Patient Problem Wound Dehiscence (1154)

Event Date 11/18/2020

Event Type  Injury  

Manufacturer Narrative

The device has not been returned for evaluation.Root cause is unable to be determined at this time.

Event Description

Information was received that removal procedure was performed (b)(6) 2020 due to wound breakdown.As per the reporter, the wound was irrigated and debrided.The patient was switched to external fixation to complete their lengthening treatment.

• Brand Name: PRECICE PLATING SYSTEM
• Type of Device: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise dr, suite 100; aliso viejo CA 92656
• Manufacturer (Section G): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise dr, suite 100; aliso viejo CA 92656
• Manufacturer Contact: tiara rae ; 101 enterprise dr, suite 100; aliso viejo, CA 92656 ; 6197314188
• MDR Report Key: 11363723
• MDR Text Key: 233035611
• Report Number: 3006179046-2021-00142
• Device Sequence Number: 1
• Product Code: KTT
• UDI-Device Identifier: 00887517021687
• UDI-Public: 887517021687
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192181
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: LP4.5-MLT4B
• Device Lot Number: 0071317AAA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/27/2021
• 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 Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 6 YR
• Patient Weight: 39