MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - RODS; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

This report is for an unk - rod: spine/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

Libit was reported that on (b)(6) 2019, an unknown spine implant broke.This complaint was identified during reverse logistics audit process of returned devices at millstone.There was no patient involvement.This report is for 3 of 3 for (b)(4).

• Brand Name: UNK - RODS
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 9257084
• MDR Text Key: 191034637
• Report Number: 2939274-2019-61835
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/14/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1