MAUDE Adverse Event Report: NUVASIVE THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM; NUVASIVE POLYAXIAL SPINAL SCREWS

Model Number	8806550A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product has been returned for evaluation as product remains in-situ.Radiographs provided confirmed the alleged event.It is unknown if patient followed post-operative activity restrictions.The root cause of the screw fracture is unknown at this time.No revision procedure has been reported.Potential adverse events and complications.".As with any major surgical procedures, there are risks involved in orthopedic surgery." ".Potential risks identified with the use of this system, which may require additional surgery, include: bending, fracture or loosening of implant component(s)." patient education: ".The patient should be instructed to limit postoperative activity, as this will reduce the risk of bent, broken or loose implant components.The patient must be made aware that implant components may bend, break or loosen even though restrictions in activity are followed." post-operative warnings ".During the postoperative phase it is of particular importance that the physician keeps the patient well informed of all procedures and treatments.Damage to the weight-bearing structures can give rise to loosening of the components, dislocation and migration, as well as to other complications.".
Event or Problem Description
On (b)(6) 2018, patient underwent a spinal procedure due to a fracture at the t12 level.The patient received instrumentation from t11-l1.On 2/15/2019, it was reported shank broke away from the tulip head.A revision procedure has not been performed at this time.No patient injury has been reported.

• Brand Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Common Device Name: NUVASIVE POLYAXIAL SPINAL SCREWS
• Manufacturer (Section D): NUVASIVE; 7475 lusk boulevard; san diego CA 92121
• MDR Report Key: 8396667
• Report Number: 2031966-2019-00167
• Device Sequence Number: 222981
• Product Code: NKB
• UDI-Device Identifier: 00887517450661
• UDI-Public: 887517450661
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K121619
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 8806550A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2019
• Initial Report FDA Received Date: 03/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 85 YR