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

Device Problem Unintended Movement (3026)

Patient Problems Failure of Implant (1924); Non-union Bone Fracture (2369)

Event Type  Injury  

Manufacturer Narrative

Patient weight not available for reporting date of event: date of device breakage and non-union is not known.This report is for an unknown quantity of unknown locking screws/unknown lot.Part and lot numbers are unknown; udi number is unknown.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.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 (b)(6) 2012, for treatment for a t12-ilium posterior spinal fusion using the synthes dual opening universal spine system (uss) implants.The patient was originally implanted with two (2) uss 6.0mm/ 300mm rods, uss collars for 6mm dual-opening implants, uss 11mm nuts and uss dual opening screws.On an unknown date post-operatively, it was observed thru image studies that the bilateral rod implants between l5 and s1 were broken.The patient also presented with a nonunion at the l5-s1 disc level.On (b)(6) 2018, the surgeon removed the rod implants bilaterally.The rods were removed in entirety without any fragments in four (4) segments.The surgeon also replaced some of the uss dual opening screws that were deemed to be loose in bone.It is unknown which of the dual opening screws were replaced.All implants have been retained by the patient.Revision surgery was completed successfully with no time delay.The patient is reported in stable condition.Sales consultant has no more information to report on this event.Concomitant devices reported: titanium 12 point nut 11mm (499.294, lot number unknown, quantity unknown); titanium collar for 6mm dual opening implants (499.292, lot number unknown, quantity unknown).This report is for unknown quantity of unknown locking screws.This is report 3 of 3 for (b)(4).

• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7314585
• MDR Text Key: 101564345
• Report Number: 2939274-2018-50887
• Device Sequence Number: 1
• Product Code: HWC
• 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,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 02/05/2018

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/05/2018
• Initial Date FDA Received: 03/05/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 31 YR