MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.0MM TI CERV SELF-RETAIN SCR SLF-DRLG/VARIABLE ANGLE 18MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	04.613.518
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient id: (b)(6).Exact date of event is unknown; event reportedly occurred sometime in 2019.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.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 patient underwent an anterior cervical fusion revision surgery to replace the two (2) titanium cervical self-retain screws self-drilling/variable angle 18mm in the unknown plate.The patient came to office for after surgery follow up with routine x-rays.The surgeon noticed bottom screws of the construct were protruding from plate.The date of original implant was (b)(6) 2019.It is unknown if there was surgical delay.Procedure outcome is unknown.No patient consequence.Concomitant device reported: plate (part/lot unknown, quantity 1).This report is for a titanium cervical self-retain screw.This is report 1 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.It was reported that on (b)(6) 2019, the patient underwent an anterior cervical fusion revision surgery to replace the two (2) titanium cervical self-retain screws self-drilling/variable angle 18mm in the unknown plate.The patient came to office for after surgery follow up with routine x-rays.The surgeon noticed bottom screws of the construct were protruding from plate.The date of original implant was january 4, 2019.It is unknown if there was surgical delay.Procedure outcome is unknown.No patient consequence.Flow: broken.Visual inspection: the x-ray of the 4.0 mm ti cervical self-retaining screw self-drilling/variable angle 18 mm (part # 04.613.518, lot # unknown) was received at us cq.The x-ray shows that the screw backed out.This is consistent with the reported complaint condition, thus confirming the complaint.Document/specification review: the following drawing(s) was reviewed; 4.0 mm ti variable angle screw cancellous.Self-drilling: 04.613.512.A dhr review could not be performed as the lot number is unknown.Conclusion: the complaint condition is confirmed as the x-ray shows the 4.0 mm ti cervical self-retaining screw self-drilling/variable angle 18 mm (part # 04.613.518, lot # unknown) backed out of the plate.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.
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.Update the investigation results to remove a typo.It was reported that on (b)(6) 2019, the patient underwent an anterior cervical fusion revision surgery to replace the two (2) titanium cervical self-retain screws self-drilling/variable angle 18mm in the unknown plate.The patient came to office for after surgery follow up with routine x-rays.The surgeon noticed bottom screws of the construct were protruding from plate.The date of original implant was (b)(6) 2019.It is unknown if there was surgical delay.Procedure outcome is unknown.No patient consequence.Visual inspection: the x-ray of the 4.0 mm ti cervical self-retaining screw self-drilling/variable angle 18 mm (part # 04.613.518, lot # unknown) was received at us cq.The x-ray shows that the screw backed out.This is consistent with the reported complaint condition, thus confirming the complaint.Document/specification review: the following drawing(s) was reviewed; 4.0 mm ti variable angle screw cancellous.Self-drilling: 04_613_512.A dhr review could not be performed as the lot number is unknown.Conclusion: the complaint condition is confirmed as the x-ray shows the 4.0 mm ti cervical self-retaining screw self-drilling/variable angle 18 mm (part # 04.613.518, lot # unknown) backed out of the plate.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.

• Brand Name: 4.0MM TI CERV SELF-RETAIN SCR SLF-DRLG/VARIABLE ANGLE 18MM
• 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: 8390280
• Report Number: 2939274-2019-56798
• Device Sequence Number: 2639654
• Product Code: KWQ
• UDI-Device Identifier: 10705034737669
• UDI-Public: (01)10705034737669
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K071667
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/08/2019

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: Health Professional
• Device Model Number: 04.613.518
• Device Catalogue Number: 04.613.518
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/08/2019
• Supplement Date Received by Manufacturer: 04/01/2019; 04/04/2019
• Initial Report FDA Received Date: 03/05/2019
• Supplement Report FDA Received Date: 04/02/2019; 04/05/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Weight: 101