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

Model Number STL5514-00

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Neurological Deficit/Dysfunction (1982)

Event Date 01/05/2017

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 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 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.

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 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.

Manufacturer Narrative

Device not returned to manufacturer.

Event Description

No further information to report.

• Brand Name: STALIF L
• Type of Device: INTERVERTEBRAL FUSION DEVICE, LUMBAR
• Manufacturer (Section D): CENTINEL SPINE, INC.; 900 airport rd, suite 3b; west chester PA 19380
• Manufacturer (Section G): ELITE MEDICAL; 8415 wolf lake drive; bartlett TN 38133
• Manufacturer Contact: hayley-ann parry ; 900 airport rd, suite 3b; west chester, PA 19380 ; 4848878814
• MDR Report Key: 6306074
• MDR Text Key: 66656920
• Report Number: 3007494564-2017-00001
• Device Sequence Number: 1
• Product Code: OVD
• UDI-Device Identifier: 00815101022321
• UDI-Public: 00815101022321
• Combination Product (y/n): N
• PMA/PMN Number: K130461
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/12/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/29/2015
• 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): Hospitalization
• Patient Age: 46 YR