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

Model Number	C127561-3T
Medical Device Problem Codes	Malposition of Device (2616); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	05/03/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was returned and a visual inspection conducted.There was some damage to the peek which could be attributed to the removal of the device but there was nothing to indicate there were any issues with the device that could have contributed to it being placed off midline.No specific measurable evaluations were carried out other than a complete dhr review.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 occurence and fully mitigated within the corresponding risk assessment fmeas.As of 2 june 2017, we are awaiting further information regarding the progress of the patient and confirmation that the medical intervention was to preclude a potential serious injury to complete the complaint investigation.
Event or Problem Description
A stalif c device implanted around (b)(6) 2016 was required to be revised on (b)(6) 2017.The patient had been experiencing discomfort and on a follow up x-ray it was noted that the implant was off midline.The surgeon had felt that the implant was not the cause of the problem, it was the poor positioning.As of (b)(6) 2017, no follow up information had been received and the complaint is still open pending further communication.

• Brand Name: STALIF C
• Common Device Name: INTERVERTEBRAL FUSION DEVICE, CERVICAL
• Manufacturer (Section D): CENTINEL SPINE, INC.; 900 airport rd, suite 3b; west chester PA 19380
• MDR Report Key: 6609530
• Report Number: 3007494564-2017-00002
• Device Sequence Number: 838545
• Product Code: OVE
• UDI-Device Identifier: 00815101022321
• UDI-Public: 00815101022321
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K150053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/06/2017

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: 04/17/2019
• Device Model Number: C127561-3T
• Device Catalogue Number: C127561-3T
• Device Lot Number: 2016-063
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2017
• Initial Report FDA Received Date: 06/02/2017
• 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