MAUDE Adverse Event Report: CENTINEL SPINE, INC. STALIF C; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, CERVICAL

Model Number	ABS1540
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Spinal Column Injury (2081); Neck Pain (2433)
Date of Event	08/24/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of sterilization and manufacturing records indicate no abnormalities or non-conformances that would have contributed to this issue.All product accepted to stock were evaluated to be within specifications with all inspection and certification present and correct.Review of risk documentation shows that the rates are within those evaluated for probability of occurrence and fully mitigated within the corresponding risk assessment fmeas.
Event or Problem Description
A complaint was received (b)(6) 2017 indicating the following: patient presented 4-6 weeks post op complaining of neck pain.Xrays confirmed a c5 vertebral body fracture.At the time of initial communication a revision had been performed.Initial information received indicated that the device was not contributorily.Further communication was received (b)(6) 2017 which stated that the surgeon did feel that the device may have been contributorily to the fracture occurring and therefore this report is being submitted within 30 days of that communication.Original surgery was completed on (b)(6) 2017 for levels c3-c5.The procedure implanted 2 stalif c-ti cages and 6 stalif c abo screws.It was reported that a hardware failure occurred as a result of the vertebral body fracture.Post fracture the screws lost purchase and the implant became loose.It is believed that this case may have been affected by osteoporosis along with aggressive endplate preparation.The surgeon felt that a crack in the vertebral body may have been initiated by the hole from the caspar pin and after aggressive endplate preparation this crack could have migrated to the nearest implanted screw and the fracture could have occurred.Revision surgeries were required and occurred on (b)(6) and (b)(6).A competitor's corpectomy spacer system was used to treat the vertebral body fracture.It was indicated that the patient was doing "excellent" after revision surgery.This is report 2 of 2 for 2 stalif c abo screws implanted into the vertebral body.

• Brand Name: STALIF C
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, CERVICAL
• Manufacturer (Section D): CENTINEL SPINE, INC.; 900 airport rd, suite 3b; west chester PA 19380
• MDR Report Key: 9088037
• Report Number: 3007494564-2017-00004
• Device Sequence Number: 2528399
• Product Code: OVE
• UDI-Device Identifier: 00815101029023
• UDI-Public: 00815101029023
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K150053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/20/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/27/2019
• Device Model Number: ABS1540
• Device Lot Number: 2016-487
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/27/2017
• Initial Report FDA Received Date: 09/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR