MAUDE Adverse Event Report: CENTINEL SPINE, INC. MIDLINE II-TI; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR

Model Number	M421312C
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Local Reaction (2035)
Date of Event	09/19/2017
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
It was communicated that a revision surgery was to be performed for a midline ii implantation that had originally been performed on (b)(6) 2016.The implantation included a midline ii-ti cage and 3 x stalif midline screws and additional posterior hardware from an alternative manufacturer.Follow-up imaging noted what appeared to be a reaction around the alternative manufacturer's titanium pedicle screws and to a lesser extent around the midline ii-ti and stalif midline screws.The revision surgery was confirmed and took place on (b)(6) 2017 to remove all titanium devices and replacing with peek only and allograft.The initial contact form was received on (b)(6) 2017 confirming that the reaction was potentially caused by an allergic reaction to the titanium.This has not yet been confirmed by an allergist.The revision surgery was completed successfully and the patient was reported to be doing well.This report is being submitted within 30 days of the completed revision surgery indicating the possibility of allergic reaction to titanium.This report is 1 of 4 for 1 midline ii-ti cage and 3 x stalif midline abo screws.

• Brand Name: MIDLINE II-TI
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR
• Manufacturer (Section D): CENTINEL SPINE, INC.; 900 airport rd, suite 3b; west chester PA 19380
• MDR Report Key: 9088312
• Report Number: 3007494564-2017-00005
• Device Sequence Number: 19316423
• Product Code: OVD
• UDI-Device Identifier: 00815101021867
• UDI-Public: 00815101021867
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K150643
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• 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): 10/19/2017

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: 10/10/2018
• Device Model Number: M421312C
• Device Lot Number: 2014-314
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/10/2017
• 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: 35 YR