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

Model Number STM6035

Device Problems Device Appears to Trigger Rejection (1524); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Local Reaction (2035)

Event Date 09/19/2017

Event Type  Injury  

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 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 10/10/17 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 4 of 4 for 1 midline ii-ti cage and 3 x stalif midline abo screws.

• Brand Name: STALIF MIDLINE
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR
• Manufacturer (Section D): CENTINEL SPINE, INC.; 900 airport rd, suite 3b; west chester PA 19380
• Manufacturer (Section G): INTAI TECHNOLOGY CORP. IMPLANTS BUSINESS UNIT; no.9 jingke road, nantun dist.; taichung city, ; TW
• Manufacturer Contact: hayley-ann parry ; 900 airport rd, suite 3b; west chester, PA 19380 ; 4848878814
• MDR Report Key: 9088354
• MDR Text Key: 162601389
• Report Number: 3007494564-2017-00008
• Device Sequence Number: 1
• Product Code: OVD
• UDI-Device Identifier: 00815101021867
• UDI-Public: 00815101021867
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150643
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2019
• Device Model Number: STM6035
• Device Lot Number: 2015-145
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 35 YR