MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 7.0MM TI SIDE-OPENING SCREW 45MM; ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION

Model Number	498.745
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Pain (1994); Nonunion/Delayed-union Bone Fracture (2369); No Code Available (3191)
Date of Event	01/23/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.Patient weight not provided for reporting.Date of event: unknown when pain, break or non-union started.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4): the complaint indicated that the screw broke post-op requiring additional surgical intervention.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 patient underwent a revision of synthes uss hardware since the patient experienced pain and one (1) left s1 screw broke due to nonunion.The patient underwent a posterior lumbar spine fusion with synthes uss on (b)(6) 2010 for an unknown spinal fracture.Subsequently, nonunion and broken screw were identified in follow-up x-rays and the surgeon decided to revise all hardware.All hardware was removed except the shaft of the broken left s1 screw which was not retrievable.The patient was revised to one (1) new screw bilaterally at l5 level, one (1) right s1 and bilaterally in the ilium (extended to the ilium) and by connecting new rods.The procedure was completed successfully.The patient condition was reported to be most likely stable.This complaint involves one (1) device.Concomitant devices reported: titanium nuts (part# 498.003, lot# unknown, quality# 4); titanium collars with grooves (part# 498.011, lot# unknown, quantity# 4); 6 mm titanium hard rods (part# 498.102, lot# unknown, quantity# 2); unknown uss screws (part# unknown, lot# unknown, quantity# unknown).This report is 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Additional device product codes: mni, kwp, kwq, nkb.Therapy date: (b)(6) 2010.A device history record (dhr) review was performed on part no: 498.745, lot no: 6306645: manufacturing site: (b)(4), release to warehouse date: 27-jan-2010, supplier dhr: n/a: no non-conformance reports (ncrs) were generated during production.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 condition.Date reported incorrectly on initial medwatch.The date should have been (b)(6) 2018.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: 7.0MM TI SIDE-OPENING SCREW 45MM
• 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: 7275440
• Report Number: 2939274-2018-50648
• Device Sequence Number: 18862799
• Product Code: MNH
• UDI-Device Identifier: 10705034791616
• UDI-Public: (01)10705034791616(10)6306645
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K141897
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2018

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: 498.745
• Device Catalogue Number: 498.745
• Device Lot Number: 6306645
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/24/2018
• Supplement Date Received by Manufacturer: 03/23/2018
• Initial Report FDA Received Date: 02/15/2018
• Supplement Report FDA Received Date: 03/23/2018
• 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: 34 YR