MAUDE Adverse Event Report: CENTINEL SPINE, INC. STALIF L; INTERVERTEBRAL FUSION DEVICE, LUMBAR

Model Number	STL5514-00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Neurological Deficit/Dysfunction (1982)
Date of Event	01/05/2017
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 complaint log shows no other complaints recorded in relation to this issue for stalif l devices.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 (b)(6) 2017, we are awaiting further information regarding the progress of the patient to complete the complaint investigation.Device not returned to manufacturer.
Event or Problem Description
A call was received communicating that a patient who had undergone a stalif l implantation on (b)(6) 2017 was experiencing nueropraxia.Follow up information communicated that the patient had regained 60% of neuropraxia and appeared to be recovering appropriately.It was unable to be confirmed which side the neuropraxia was occurring.Further feedback has been requested from the distributor but as of (b)(6) 2017, no further information has been received.
Additional Manufacturer Narrative
Complaint was updated and closed on (b)(6) 2017 to include additional follow up information that there were no further patient issues.Complaint trending will be monitored.Device not returned to manufacturer.
Event or Problem Description
Further feedback from (b)(6) 2017 indicated that the surgeon did not believe that the device had been contributory to the issue and no further patient issue or problems were reported during post op follow ups.The surgeon had been very happy with the placement of the implant and did not feel that any revision surgery would be necessary.
Additional Manufacturer Narrative
Device not returned to manufacturer.
Event or Problem Description
No further information to report.

• Brand Name: STALIF L
• Common Device Name: INTERVERTEBRAL FUSION DEVICE, LUMBAR
• Manufacturer (Section D): CENTINEL SPINE, INC.; 900 airport rd, suite 3b; west chester PA 19380
• MDR Report Key: 6306074
• Report Number: 3007494564-2017-00001
• Device Sequence Number: 512295
• Product Code: OVD
• UDI-Device Identifier: 00815101022321
• UDI-Public: 00815101022321
• Combination Product (Y/N): N
• PMA/510(K) Number: K130461
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/06/2017

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: 05/10/2019
• Device Model Number: STL5514-00
• Device Catalogue Number: STL5514-00
• Device Lot Number: 2016-026
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/19/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 02/06/2017
• Supplement Report FDA Received Date: 06/02/2017; 06/06/2017
• 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: Hospitalization
• Patient Age: 46 YR