MAUDE Adverse Event Report: BIOGENNIX, LLC SYPHER ALIF SPACER SYSTEM

Model Number	N/A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/08/2016
Type of Reportable Event	Malfunction
Event or Problem Description
During a procedure, on (b)(6) 2016, the doctor encounter an osteophyte near the implant site that impeded direct alignment of the sypher locking cover plate assembly to the implanted sypher spacer.The cover plate screw and the spacer insert were not properly aligned using the free-hand technique, resulting in cross-threading of the screw into the spacer insert to a degree that prevented the screw from being fully seated as well as impossible to remove the screw by unscrewing it from the cover plate.The doctor then attempted to remove the locking cover plate screw using pliers and in the process the spacer insert was pulled out of the spacer along with the locking cover plate assembly.Since the sypher spacer was firmly fixed in place with the three sypher titanium screws, the doctor decided to finish the procedure without a locking cover plate assembly.In a follow-up with the doctor on (b)(6) 2016, he indicated that the patient was doing well and that in future situations he would remove any obstructing osteophytes prior to sypher spacer implantation.Biogennix assessment: biogennix received the returned sypher locking plate assembly components related to this complaint.The investigation concluded that this complaint was a result of misalignment and cross-threading of implant components due to an osteophyte location that prevented aligned access to the implant.Visual assessment and the doctor's description of events indicate that the sypher locking plate assembly met all the specification requirements and no additional action is required as a result of this complaint.Field experience will be monitored for similar occurrence.

• Brand Name: SYPHER ALIF SPACER SYSTEM
• Common Device Name: SYPHER ALIF SPACER SYSTEM
• Manufacturer (Section D): BIOGENNIX, LLC; 18007 sky park cir ste f; irvine 92614
• MDR Report Key: 6146011
• Report Number: 3008773560-2016-00004
• Device Sequence Number: 19100210
• Product Code: MAX
• UDI-Device Identifier: 00812593020330
• UDI-Public: 00812593020330
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K141798
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/01/2016

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: No Information
• Device Expiration Date: 08/26/2017
• Device Model Number: N/A
• Device Catalogue Number: SAS-3212
• Device Lot Number: 1592
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2016
• Initial Report FDA Received Date: 12/05/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other