MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.0MM TI CANCELLOUS POLYAXIAL SCREW 30MM; ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION

Model Number	04.614.130
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of device breakage and non-union is not known.Additional product codes: kwp, mnh, mni.(b)(4).Date of implant reported as (b)(6) 2015.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 or Problem Description
It was reported the patient had a c2-t1 posterior cervical fusion with synthes synapse 3.5mm rod system in (b)(6) 2015.The synapse screws were in c2, c4, c6 and t1 bilaterally.At an unknown point in time, the t1 synapse screws broke bilaterally due to nonunion.The screws broke off just below the head on the synapse screws.On (b)(6) 2018 a revision was performed to address the non union and the broken screws in t1.First the locking caps and rods were removed.A decision was made to use the synapse 4.0mm rod system with the larger diameter rod.Then all the existing synapse 3.5mm rod system screws were removed and replaced with synapse 4.0 rod sytem screws (did not replace the t1 screws).There were no hardware related issues except for the two broken t1 screws.The surgeon was able to remove all the hardware except the left t1 broken screw which remained in the patient.He was able to retrieve the right t1 broken screw.New synapse 4.0mm rod system screws were placed in t2 and t3.He then contoured new rods and secured them to the screws with new synapse locking caps.The new construct is from c2-t3.He successfully completed the procedure.Concomitant devices reported: titanium locking screw (04.614.508, lot number unknown, quantity 2), rod (part number unknown, lot number unknown, quantity 2).This report is for one (1) 4.0mm titanium cancellous polyaxial screw 30mm.(b)(4).
Additional Manufacturer Narrative
Device could not be removed during revision surgery, as such explant date is not applicable.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.

• Brand Name: 4.0MM TI CANCELLOUS POLYAXIAL SCREW 30MM
• Common Device Name: ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7267756
• Report Number: 2939274-2018-50617
• Device Sequence Number: 1736904
• Product Code: NKG
• UDI-Device Identifier: 10705034738642
• UDI-Public: (01)10705034738642(10)LOTUNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K142838
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2018

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
• Operator of Device: Health Professional
• Device Model Number: 04.614.130
• Device Catalogue Number: 04.614.130
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/22/2018
• Supplement Date Received by Manufacturer: 03/21/2018
• Initial Report FDA Received Date: 02/13/2018
• Supplement Report FDA Received Date: 03/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 42 YR