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

Model Number P8.5-50C195

Device Problem Material Integrity Problem (2978)

Patient Problem No Code Available (3191)

Event Type  Injury  

Event Description

It was reported that allegedly the patient's precice nail appeared to not be lengthening.The device was removed and the physician implanted a new nail without incident.

Manufacturer Narrative

(b)(4).

• Brand Name: PRECICE® INTRAMEDULLARY LIMB LENGTHENING ROD
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise, suite 100; aliso viejo CA 92656
• Manufacturer (Section G): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise, suite 100; aliso viejo CA 92656
• Manufacturer Contact: john mcintyre ; 101 enterprise, suite 100; aliso viejo, CA 92656
• MDR Report Key: 6822919
• MDR Text Key: 83726490
• Report Number: 3006179046-2017-00044
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/26/2017

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
• Device Operator: Physician
• Device Model Number: P8.5-50C195
• Device Catalogue Number: P8.5-50C195
• Device Lot Number: A161215-19-0AA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/26/2017
• Initial Date FDA Received: 08/25/2017
• Supplement Dates Manufacturer Received: 07/26/2017
• Supplement Dates FDA Received: 10/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 17 YR
• Patient Weight: 52