MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC; INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION, LUMBAR

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Additional patient id (b)(4).Patient weight was not provided for reporting.Date of event is unknown.This report is for one (1) unknown pdl superior endplate.Part#, lot# and udi # is not available.Date of implant is unknown.Device is not expected to be returned for manufacturer review/investigation.This report is for one (1) unknown pdl superior endplate.Pma/510(k) number is not available.Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Additionally, device history records review could not be completed without lot number.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 the patient had original surgery on an unknown date for treatment with a (pdl) prodisc l artificial disc replacement.On an unknown date post-operative, patient presented with pain and other unknown medical issues.On (b)(6) 2018, surgeon removed the pdl implant and revised the patient to centinel spine interbody fusion device and posterior fixation.Surgeon felt that the patient would benefit more from a fusion at the pdl level.It was reported that there was no malfunction of the device.No fragments were generated during implant removal.Revision surgery was completed successfully with no time delay.This report is for one (1) unknown pdl superior endplate this is report 1 of 3 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.Pre-existing condition was updated.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.

• Type of Device: INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION, LUMBAR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7611712
• MDR Text Key: 111405931
• Report Number: 2939274-2018-52532
• Device Sequence Number: 1
• Product Code: OVD
• 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
• Report Date: 05/16/2018

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: 06/14/2018
• Initial Date FDA Received: 06/18/2018
• Supplement Dates Manufacturer Received: 07/02/2018
• Supplement Dates FDA Received: 07/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 43 YR