MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - SCREWS; SCREW,FIXATION,BONE

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown screw/unknown lot.Part and lot numbers are unknown; udi number is unknown.The investigation could not be completed; no conclusion could be drawn, as no product was received.(b)(4).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 Description

It was reported that a patient underwent two or three level anterior cervical discectomy fusion (acdf) at the c4-c7 levels on (b)(6) 2017.The patient was implanted with a vectra plate, unknown screws, three (3) vertigraft spacers with central lumen and a vivigen pouch.In (b)(6) 2018, the patient presented with right hand paresthesias and fall.Fall was resolved without residual effect also in (b)(6) 2018.On (b)(6) 2019, the patient fell 8 ft off a ladder and was resolved without sequela on the same day.Concomitant devices reported: vertigraft spacer (part# 017207, lot# unknown, quantity 1), vertigraft spacer (part# 017208, lot# unknown, quantity 1), vertigraft spacer (part# 017209, lot# unknown, quantity 1), vivigen pouch (part# bl-1500-001, lot# unknown, quantity 1).This report is for one (1) screws.This is report 2 of 2 for (b)(4).

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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Awareness date reported as date but should have been january 09, 2020.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.

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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Product was not returned.Based on the information available, it has been determined that no corrective and 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 Description

Concomitant devices reported: ti vectra(tm) plate 3 level/54mm (part# 04.613.254, lot# 43469, quantity 1).

• Brand Name: UNK - SCREWS
• Type of Device: SCREW,FIXATION,BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9621594
• MDR Text Key: 189594350
• Report Number: 2939274-2020-00360
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 12/27/2018

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/23/2020
• Initial Date FDA Received: 01/23/2020
• Supplement Dates Manufacturer Received: 01/23/2020; 06/04/2020
• Supplement Dates FDA Received: 01/23/2020; 06/08/2020
• Patient Sequence Number: 1
• Treatment: TI VECTRA(TM) PLATE 3 LEVEL/54MM
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Weight: 101