MAUDE Adverse Event Report: INNOVASIS, INC. EXCELLA III-D SPINAL DEFORMITY SYSTEM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	E2002
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/08/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Event occurred in (b)(4), peru wherein a patient had a spinal deformity construct of multiple pedicle screws implanted with rods and locking caps.At a two-week post-operative follow-up, the patient had noticeable deformity, pain and functional limitation.Imaging showed multiple locking caps came loose, releasing the rods from the construct in the lumbosacral area.Revision surgery was performed to replace 8 of the original 18 screws and locking caps, while the remaining screws, locking caps and rods remained.

• Brand Name: EXCELLA III-D SPINAL DEFORMITY SYSTEM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): INNOVASIS, INC.; 614 e 3900 s; salt lake city UT 84107 1902
• Manufacturer (Section G): INNOVASIS, INC.; 614 e 3900 s; salt lake city UT 84107 1902
• Manufacturer Contact: michael thomas ; 614 e 3900 s; salt lake city, UT 84107-1902 ; 8012612236
• MDR Report Key: 15933630
• Report Number: 3004719693-2022-00002
• Device Sequence Number: 4347762
• Product Code: NKB
• UDI-Device Identifier: M711E20020
• UDI-Public: +M711E20020/$$72010/Q1R
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K140238
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/07/2022

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
• Operator of Device: Health Professional
• Device Model Number: E2002
• Device Catalogue Number: E2002
• Device Lot Number: 2010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/10/2022
• Initial Report FDA Received Date: 12/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/08/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 13 YR
• Patient Sex: Unknown