MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC ZERO-P VA IMPLANT 8MM HEIGHT CONVEX-STERILE; INTERVERTEBRAL FUSION DEVICE

Model Number	04.647.138S
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: part: 04.647.1038s; lot: l969600; manufacturing site: (b)(4); release to warehouse date: july 16, 2018; expiry date: july 01, 2028.60010139, round 20.0mm peek optima with lot number l856159 was identified as used raw material.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Visual inspection: the zero-p va implant 8mm height convex-sterile was received at us customer quality (cq) with the peek portion of the device separated from the titanium plate.The peek showed some fragments have broken off from the device.This is consistent with the reported complaint condition, thus confirming the complaint.Functional test: the peek portion of the device was able to click into place onto the titanium plate.It is difficult to separate the two pieces of the device once they have been clicked into position therefore the complaint could not be replicated.However, during surgery, when the screws are being placed into the device, it is highly likely that the forces involved could have caused the separation of the titanium plate from the peek.Dimensional inspection: dimensional analysis was completed.The inner length of the titanium plate where the peek clicks in measured within specification, based on drawing.The outer length of the peek where it clicks onto the titanium plate measured within specification, based on drawing.Document/specification review: the following drawings were reviewed: plate_complete, plate size 5 ¿ 12, spacer convex size 5 ¿ 12 peek.60010139 round 20.0mm peek optima with lot number l856159 was identified as used raw material.Conclusion: the complaint condition is confirmed as the zero-p va implant 8mm height convex-sterile was received with the peek portion of the device separated and chipped with fragments missing from the device.There is no indication that a design or manufacturing issue contributed to the complaint.While no definitive root cause could be determined, it is possible that the device encountered unintended forces.No new malfunctions were observed during the course of this investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Device was used for treatment, not diagnosis.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 on (b)(6) 2019, the surgeon was performing a c3-c7 anterior cervical discectomy and fusion (acdf) at levels c3-4, c4-5, and c5-6.When the surgeon implanted a zero-p va implant at c6-7, it was noticed that something appeared wrong with the cage.The surgeon put in a 3.7 cervical spine screw 16mm and a 3.7 cervical spine screw 18mm to lock it in place per the recommended technique, but was still not satisfied.The surgeon commented that the cage had separated from the plate.He removed the cage, plate and two (2) screws and requested different implants.A new implant was opened and the procedure was concluded as planned.There was a surgical delay of five (5) minutes.No patient consequence was reported.This report is for a zero-p va implant.This is report 3 of 3 for (b)(4).

• Brand Name: ZERO-P VA IMPLANT 8MM HEIGHT CONVEX-STERILE
• Common Device Name: INTERVERTEBRAL FUSION DEVICE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8449014
• Report Number: 2939274-2019-57111
• Device Sequence Number: 16908468
• Product Code: OVE
• UDI-Device Identifier: 10705034750828
• UDI-Public: (01)10705034750828
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 02/01/2019

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 Model Number: 04.647.138S
• Device Catalogue Number: 04.647.138S
• Device Lot Number: L969600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/21/2019
• Initial Report FDA Received Date: 03/25/2019
• Patient Sequence Number: 1
• Patient Age: 50 YR