MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - MONO/POLYAXIAL SCREWS: MATRIX; PLATE,FIXATION,BONE

Catalog Number UNK - MONO/POLYAXIAL SCREWS: M

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

Patient Problems Foreign Body Reaction (1868); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

This report is for an unk - mono / polyaxial screws: matrix/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.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.Without a lot number the device history records review could not be completed.Product was not returned.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 on an unknown date, the patient underwent posterior lumbar revision of matrix system, six (6) screws, six (6) locking caps, and two (2) rods, due to pain.There was no mention of adjacent level disease.The surgeon used a laser during the initial surgery to control bleeding.The initial surgery was in 2016.There was metal debris in the wound and it was arching during electrocautery.Lab was testing material and tissue.Irrigation and debris were emended.The patient was having pain was the reason for the revision, there was no mention of adjacent level disease.The patient was implanted with a competitor¿s implant at the same levels.It is unknown if there was surgical delay.Procedure and patient outcome were unknown.This is report 6 of 10 for (b)(4).

Manufacturer Narrative

(b)(4).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.Concomitant medical products: complainant part is not expected to be returned for manufacturer review/investigation.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 hospital is still reviewing the implants.

• Brand Name: UNK - MONO/POLYAXIAL SCREWS: MATRIX
• Type of Device: PLATE,FIXATION,BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9386031
• MDR Text Key: 168461189
• Report Number: 2939274-2019-62417
• Device Sequence Number: 1
• Product Code: HRS
• 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: 10/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK - MONO/POLYAXIAL SCREWS: M
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/10/2019
• Patient Sequence Number: 1