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

Device Problem Unintended Movement (3026)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

510k: this report is for an unknown uss locking screw/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 a posterior spinal fusion with a combination of synthes universal spine system (uss) and synthes uss variable access screw (vas) iii on (b)(6) 2016.At an unknown point in time, the patient broke the right rod between l5 and s1 disc space.Post-operative, on (b)(6) 2017, surgeon performed the revision.Surgeon removed all the uss and uss vas iii nuts and collars below t12.At t12 there was also a extension connector connecting rods cranial and caudal to the connector.Surgeon then removed both the left and right rods below the connector.Surgeon then replaced several loose screws at unknown levels - unknown screws that came out or were replaced.Surgeon then contoured new rods and placed them into the existing extension connectors.He then connected the rods to the screws.He then replaced the right and left iliac screws, and then placed a second set of iliac screws bilaterally and connected them to the rods.Surgery was complete successfully and patient is reported in stable condition.Concomitant devices reported: titanium nut 11mm width across flats (498.003, lot number unknown, quantity unknown), titanium collar for uss variable axis screws (497.140, lot number unknown, quantity unknown), 6.0mm titanium collar (498.010, lot number unknown, quantity unknown), titanium extension connector 6.0mm/6.0mm (498.165, lot number unknown, quantity unknown).This report is for one (1) unknown uss locking screw this is report 2 of 2 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: 7371473
• MDR Text Key: 103516839
• Report Number: 2939274-2018-51219
• 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: 02/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2018
• 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
• Date Manufacturer Received: 02/26/2018
• 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: 61 YR