MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 6.0MM TI HARD ROD 75MM; ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION

Model Number	498.103
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); Nonunion/Delayed-union Bone Fracture (2369)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional device product codes: mni, kwp, kwq, nkb.Implanted on an unknown date in (b)(6) 2003.Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.A review of the device history records has been requested and is currently pending completion.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 that on (b)(6) 2018, a revision surgery was performed for the patient who was treated for an l1 burst fracture on (b)(6) 2003 by performing a t12-l2 posterior spinal fusion and pacing a synthes uss hardware.The two (2) 6.0mm ti hard rod was broken due to nonunion.All other hardware was intact.The surgeon replaced the t12 and l2 screws.He did not replace the l1 screws as the surgeon performed a pedicle subtraction osteotomy at this level to correct hyperkyphosis.The surgeon then placed new uss screws at t11 and l3 to extend construct.After performing the l1 pedicle subtraction osteotomy (pso).The procedure was successful with no reported surgical delay.Concomitant devices reported: 6.0mm ti side-opening screw 30mm (part # 498.630, lot # unknown, quantity 1), 7.0mm ti side-opening screw 50mm (part # 498.750, lot # unknown, quantity 1), ti collar with grooves (part # 498.011, lot # unknown, quantity 1), uss nut f/uss-var-axis-scr uss-pedicscr+ (part # 498.003, lot # unknown, quantity 1).This report is for one (1) 6.0mm ti hard rod 75mm.This is report 1 of 2 for complaint (b)(4).
Additional Manufacturer Narrative
Part 498.103, lot 4514189: date of manufacture: march 06, 2003.Place of manufacture: international engineering & manufacturing; brandywine plant.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint action.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: 6.0MM TI HARD ROD 75MM
• Common Device Name: ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7639655
• Report Number: 2939274-2018-52641
• Device Sequence Number: 2194503
• Product Code: MNH
• UDI-Device Identifier: 10705034788845
• UDI-Public: (01)10705034788845
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K090605
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2018

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: 498.103
• Device Catalogue Number: 498.103
• Device Lot Number: 4514189
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/01/2018
• Supplement Date Received by Manufacturer: 07/09/2018
• Initial Report FDA Received Date: 06/26/2018
• Supplement Report FDA Received Date: 07/25/2018
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE EVENT DESCRIPTION: THERAPY DATE (B)(6) 2003
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR