MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC ZERO-P VA IMPLANT 7MM HEIGHT LORDOTIC-STERILE; INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION,CERVICAL

Model Number	04.647.127S
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device malfunctioned intra-operatively and was not implanted / explanted complainant part is not expected to be returned for manufacturer review/investigation.Device history records review was conducted.The report indicates that the: part no.: 04.647.127s lot no.: 9512738 manufacturing location: (b)(4).Release to warehouse date: 12.Jun.2015 expiry date: 01.Jun.2025 no ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.The investigation could not be completed; no conclusion could be drawn, as no product was received.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that the patient had original surgery on (b)(6) 2018, for a spine fusion treatment.Inter-operative, the (zero-p va) variable angle zero-profile anterior cervical interbody fusion implant came apart upon insertion.Upon inserting the zero p va implant, the peek and titanium components separated under normal insertion conditions.Both pieces were easily retrieved and the surgeon chose another implant that was available in the operating room.Surgery was completed successfully and the patient is reported in stable condition.The implant will not be returned.Due to this issue surgery was delayed.The reporter is not sure of the exact amount of minutes concerning the delay time.No fragments were generated during the procedure.No additional x-rays were needed.Concomitant devices: insertion device for the zero-p va (item number unknown, lot number unknown, quantity unknown) unknown spine screws(item number unknown, lot number unknown, quantity 2 each) this report is for one (1) device.This report is 1 of 1 for (b)(4).

• Brand Name: ZERO-P VA IMPLANT 7MM HEIGHT LORDOTIC-STERILE
• Common Device Name: INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION,CERVICAL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7373945
• Report Number: 2939274-2018-51245
• Device Sequence Number: 11130426
• Product Code: OVE
• UDI-Device Identifier: 10705034750736
• UDI-Public: (01)10705034750736(17)250601(10)9512738
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K112068
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 02/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/01/2025
• Device Model Number: 04.647.127S
• Device Catalogue Number: 04.647.127S
• Device Lot Number: 9512738
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/27/2018
• Initial Report FDA Received Date: 03/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1