MAUDE Adverse Event Report: WRIGHTS LANE : SYNTHES USA PRODUCTS LLC 6.0MM TI COLLAR; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	498.010
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Stenosis (2263); No Code Available (3191)
Date of Event	01/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).Patient weight is unknown additional product codes: nkb, mni, mnh, kwp.Unknown date in (b)(6) 2016.Complainant part is not expected to be returned for manufacturer.Review/investigation, as it was reportedly discarded.(b)(4) used to capture degenerative disc disease.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 that a patient underwent a hardware removal and revision procedure of two (2) nuts, two (collars), and two (2) screws belonging to synthes uss construct from l2 vertebra on (b)(6) 2017.Two (2) initially implanted caudal rods were left in the patient and connected to new rods using rod to rod connectors.The patient had a l2-ilium posterior fusion with synthes uss in (b)(6) 2016.The patient is reported to have increasing back pain since the time of the initial fusion procedure, possibly due to degenerative disc disease and stenosis above the levels of the (b)(6) 2016 fusion procedure.After removing the nuts, collars and screws from l2 vertebra bilaterally, the surgeon inserted rod to rod connectors on the existing rods at l2 followed by placing new screws at t10, t11, t12 and l1.The surgeon then connected the existing caudal rods to the new cranial rods with the rod to rod connectors bilaterally, thus concluding the procedure.The removal and revision procedure was completed successfully and uneventfully with no additional interventions required.The patient is reported to be in stable condition.This is report 3 of 6 for (b)(6).
Additional Manufacturer Narrative
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 COLLAR
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): WRIGHTS LANE : SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7088560
• Report Number: 2939274-2017-50173
• Device Sequence Number: 16423929
• Product Code: KWQ
• UDI-Device Identifier: 10705034788586
• UDI-Public: (01)10705034788586(10)LOTUNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K082572
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2017

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?: No
• Operator of Device: Health Professional
• Device Model Number: 498.010
• Device Catalogue Number: 498.010
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/07/2017
• Supplement Date Received by Manufacturer: 01/05/2018
• Initial Report FDA Received Date: 12/06/2017
• Supplement Report FDA Received Date: 01/09/2018
• 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: 63 YR