MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.7MM TI CERV SPN SCR SLF-TPNG VARIABLE ANGLE 18MM-STERILE; INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION, CERVICAL

Model Number	04.647.878S
Medical Device Problem Code	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
The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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 3.7mm titanium (ti) cervical spine screw 18mm.This is report 2 of 2 for (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H3, h6: the 3.7 mm ti cerv spn scr slf-tpng variable angle 18 mm ¿ sterile (part # 04.647.878s, lot # l491940, mfg # 28-jul-2017) was received with the screw separate and not assembled with the titanium plate.The screw shows minimal signs of wear.A functional test was performed, and the screw was able to be disassembled from the titanium plate of the zero-p va implant and re-assembled.The complaint was not able to be replicated, therefore the complaint is not confirmed.The surgeon reported dissatisfaction with the way the implant appeared, and these conditions cannot be replicated.Relevant drawing was reviewed.The complaint condition is not confirmed as the 3.7 mm ti cerv spn scr slf-tpng variable angle 18 mm ¿ sterile (part # 04.647.878s, lot # l491940) was received separate from the ti plate but was able to be assembled and dis-assembled.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.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.No new malfunctions were observed during the course of this investigation.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.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H3, h6: part: 04.647.878s; lot: l491940; manufacturing site: mezzovico; release to warehouse date: july 28, 2017; expiry date: july 01, 2027.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Visual inspection: the 3.7 mm ti cerv spn slf-drilling variable angle 16 mm - sterile was received at us customer quality (cq) assembled onto the titanium plate of the zero-p va implant (part # 04.647.138s.) the screw recess looks worn.The rest of the screw shows minimal signs of wear.Functional test: a functional test was performed, and the screw was able to be disassembled from the titanium plate of the zero-p va implant and re-assembled.The complaint was not able to be replicated, therefore the complaint is not confirmed.The surgeon reported dissatisfaction with the way the implant appeared, and these conditions cannot be replicated at us cq.Dimensional inspection: dimensional analysis was not performed as there are no relevant dimensions to the complaint condition.Document/specification review: the following drawing was reviewed; cervical spine screw ø3.7*xx conclusion: the complaint condition is not confirmed as the 3.7 mm ti cerv spn slf-drilling variable angle 16 mm - sterile was received assembled unto the titanium plate and able to be disassembled and re-assembled.There is no indication that a design or manufacturing issue contributed to the complaint.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.No new malfunctions were observed during the course of this investigation.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
This is report 2 of 3 for (b)(4).

• Brand Name: 3.7MM TI CERV SPN SCR SLF-TPNG VARIABLE ANGLE 18MM-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: 8377894
• Report Number: 2939274-2019-56712
• Device Sequence Number: 2926523
• Product Code: OVE
• UDI-Device Identifier: 10705034751450
• UDI-Public: (01)10705034751450
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K121852
• 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,Followup,Followup
• 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: 04.647.878S
• Device Catalogue Number: 04.647.878S
• Device Lot Number: L491940
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2019
• Initial Date Received by Manufacturer: 02/01/2019
• Supplement Date Received by Manufacturer: 03/21/2019; 03/25/2019
• Initial Report FDA Received Date: 02/28/2019
• Supplement Report FDA Received Date: 03/25/2019; 03/26/2019
• Patient Sequence Number: 1
• Patient Age: 50 YR