MAUDE Adverse Event Report: RENOVIS SURGICAL TECHNOLOGIES S128 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM; ANTERIOR LUMBAR INTERBODY FUSION SYSTEM

Model Number UNKNOWN

Device Problem Insufficient Information (3190)

Patient Problem Failure of Implant (1924)

Event Date 06/20/2018

Event Type  Injury  

Manufacturer Narrative

The event was reported to the medwatch program (report # mw5078247) on (b)(4) 2018 by the and officially received by the fda on 7/3/2018.The reported date of the surgery on the medwatch form is (b)(6) 2017.Renovis reviewed sales records for all alif cages used in surgeries on the reported date.There were two titanium alif surgeries completed on (b)(6) 2017: the first was completed by a surgeon in (b)(6).The surgeon reviewed the patient record, including an mri, and stated that the cage in his patient has not fractured.The second was completed by a surgeon in (b)(6).Marketing reached out to the surgeon who also reviewed the patient record, including an mri, and stated that the cage in his patient has not fractured.Renovis is unable to identify the cage used or location of surgery as both surgeons that implanted titanium cages on the reported surgery date have stated that the cages in their patients have not fractured.

Event Description

Renovis received medwatch report mw5078247 through the u.S.Mail on 7/16/2018.Per the medwatch report, a voluntary event report was received for a "tesera 3-d printed alif cage." per the report, the "renovis alif cage could not withstand normal, axial load and in turn, the lateral aspect of the cage has fractured and is collapsed." this event is classified as "serious injury" per the medwatch report.

• Brand Name: S128 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM
• Type of Device: ANTERIOR LUMBAR INTERBODY FUSION SYSTEM
• Manufacturer (Section D): RENOVIS SURGICAL TECHNOLOGIES; 1901 w. lugonia ave.; suite 340; redlands CA 92374
• Manufacturer (Section G): RENOVIS SURGICAL TECHNOLOGIES, INC.; 1901 w. lugonia ave.; suite 340; redlands CA 92374
• Manufacturer Contact: anthony debenedictis ; 1901 w. lugonia ave., ste. 340; redlands, CA 92374 ; 9095572360
• MDR Report Key: 8156796
• MDR Text Key: 130173284
• Report Number: 3007932279-2018-00001
• Device Sequence Number: 1
• Product Code: OVD
• Combination Product (y/n): N
• PMA/PMN Number: K140106
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 08/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/16/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other