MAUDE Adverse Event Report: NUVASIVE, INC. LAMINOPLASTY FIXATION SYSTEM; ORTHOSIS, SPINE, PLATE. LAMINOPLSTY METAL

Model Number 7650108

Device Problem Fracture (1260)

Patient Problems Fall (1848); Pain (1994)

Event Date 09/02/2015

Event Type  malfunction  

Manufacturer Narrative

No radiographs were received and the event could not be confirmed.The implants were discarded by the hospital, no product information given and no further product investigation can be completed at this time.It is unknown if the patient complied with post-operative care instructions.The patient reportedly fell prior to the event, but it is unknown if this contributed to the event.Root cause has not been determined, no conclusion can be drawn.Product labeling indicates: "potential risks identified with the use of this device system, which may require additional surgery, include: device component fracture, loss of fixation, fracture of the vertebra, and vascular or visceral injury.If healing is delayed, or does not occur, the implant may eventually loosen, bend or break.Loads on the device produced by load bearing and by the patient's activity level will dictate the longevity of the implant".Implants were discarded by the hospital.

Event Description

Laminoplasty fixation system was implanted on (b)(6) 2015 in a (b)(6) female at c3.On (b)(6) 2015 the patient sustained a fall and was revised on (b)(6) 2015 for a lamina fracture.Patient is stable and is doing well post-revision.Implants were discarded by the hospital.No malfunction of the construct occurred.

• Brand Name: LAMINOPLASTY FIXATION SYSTEM
• Type of Device: ORTHOSIS, SPINE, PLATE. LAMINOPLSTY METAL
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk blvd; san diego CA 92121
• Manufacturer Contact: deborah silva ; 7475 lusk blvd; san diego, CA 92121 ; 8589091830
• MDR Report Key: 5094001
• MDR Text Key: 26424649
• Report Number: 2031966-2015-00053
• Device Sequence Number: 1
• Product Code: NQW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091623
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Report Date: 09/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 7650108
• Device Catalogue Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/01/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 48 YR