MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.0MM TI CERV SELF-RETAIN SCR SLF-DRLG/VARIABLE ANGLE 16MM; APPLIANCE,FIXATION,SPINAL INTERVERTEBRAL BODY

Model Number	04.613.516
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of device migration is not known complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 a patient underwent a 3-level anterior cervical interbody fusion (acif) from the c4-c7 levels on (b)(6) 2017 using the synthes vectra plating system, two levels of 7mm lordotic cortico-cancellous anterior cervical fusion (cc acf) frozen allograft, and one level of 8mm lordotic cc-acf frozen allograft.After the interbody fusions were complete, a 3-level vectra plate (48mm) was implanted along with seven (7) 4.0mm x 16 unknown screws and one (1) 4.5mm x 16 unknown screw.Prior to closing, the surgeon verified that all implants were properly placed and all of the screws were properly locked into the plate.The surgery was completed successfully and no adverse events were reported against the patient.Postoperatively, on an unknown date, x-rays were taken and it was identified that the lowest two (2) of the implanted screws at c7 had backed out of the plate by approximately 3mm.On (b)(6) 2018, the patient was returned to the operating room.During the procedure, the vectra plate and all eight (8) screws were explanted.Several of the other screws were noted to be loose; however, they were still locked into the plate.After removing the implanted devices, the patient was implanted with a 3-level skyline plate with screws.The revision surgery was completed successfully and there was no injury noted to the patient¿s esophagus.Concomitant devices reported: titanium vectra plate 3 level/48mm (part 04.613.248, lot number unknown, quantity 1) 4.0mm titanium cervical self-retaining screws (part 04.613.516, lot number unknown, quantity unknown), 4.5mm titanium cervical self-retaining screws (part 04.613.566, lot number unknown, quantity unknown) this report is for one (1) 4.0mm titanium cervical self-retaining screw this is report 1 of 3 for (b)(6).
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.Product development investigation was completed.The devices were returned to customer quality for investigation where both plate and screws were found to shows signs of wear consistent with implantation and explantation.No damage was noted on any of the implants which may have contributed to the complaint condition of postoperatively loosening/migration, as such the complaint is unconfirmed.Whether the complaint condition was able to be replicated is not applicable to a postoperatively implant failure complaint.The returned screws are a component of the vectra titanium screw set (01.613.005) which is noted in the vectra, vectra-t and vectra-one system technique guide.The returned screws are available for the use with any of the vectra, vectra-t or vectra-one plates as a variable-angle screw and features a 14-degree longitudinal range and a 28-degree latitudinal range.In each plate the screws are retained by integral elgiloy clips.Relevant drawings for the returned implants were reviewed.The current revision of the screw drawing was reviewed as a date of manufacture was unable to be determined without a lot number.The design, materials and finishing processes were found to be appropriate for the intended use of this device.No dimensional analysis is applicable due to post-manufacturing damage likely associated with device explantation.There is no indication that the screw¿s material composition contributed to the allegation of migration/loosening, as such no material testing was completed.No device history review could be performed for the returned screws as the corresponding lot number is unknown.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.

• Brand Name: 4.0MM TI CERV SELF-RETAIN SCR SLF-DRLG/VARIABLE ANGLE 16MM
• Common Device Name: APPLIANCE,FIXATION,SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7431113
• Report Number: 2939274-2018-51708
• Device Sequence Number: 13882663
• Product Code: KWQ
• UDI-Device Identifier: 10705034737645
• UDI-Public: (01)10705034737645
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K071667
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2018

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?: Yes
• Operator of Device: No Information
• Device Model Number: 04.613.516
• Device Catalogue Number: 04.613.516
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2018
• Initial Date Received by Manufacturer: 02/28/2018
• Supplement Date Received by Manufacturer: 04/24/2018
• Initial Report FDA Received Date: 04/13/2018
• Supplement Report FDA Received Date: 05/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR
• Patient Weight: 85