MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 6.0MM TI HARD ROD 150MM; ORTHOSIS,SPONDYLOSTHESIS SPINAL FIXATION

Model Number	498.106
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient¿s weight, ethnicity and race were not provided for reporting.Date of event is unknown.Additional device product codes: mni, kwp, kwq, nkb.Device is not expected to be returned for manufacturer review/investigation.(b)(4).Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Device history records review could not review has been requested.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) 2017, patient was implanted with universal spinal system (uss) from t10-ilium.All levels had screws placed from t10-ilium except l2 and at that level, the patient had a parallel connector in place that connected two (2) rods on each side.On an unknown date post-operative, the hard rods broke between l2-l3.On (b)(6) 2018, patient underwent a revision surgery due to broken bilateral titanium hard rods that were caudal to the two (2) titanium parallel connectors.During the revision, the surgeon removed all the eighteen (18) uss nuts, eighteen (18) collars, two (2) hard rods and (2) parallel connectors.The surgeon then decided to place new screws at t8 and t9, contoured new rods and connected them to the screws with new uss nuts and collars.There was no surgical delay reported.The procedure was completed successfully and there was no patient consequence.Concomitant devices reported: screws (part#: unknown, lot# unknown, quantity# unknown); titanium parallel connectors (part#: 498.160, lot# unknown, quantity# 2); titanium nuts (part#: 498.003, lot# unknown, quantity# 18); titanium collars (part#: 498.010, lot# unknown, quantity# 18).This report is for one (1) 6.0mm ti hard rod 150mm.This is report 1 of 2 for (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.A device history record review was attempted but was unable to be completed because the provided lot number 8241728 was determined not to be valid.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 150MM
• 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: 7773194
• Report Number: 2939274-2018-53268
• Device Sequence Number: 1012334
• Product Code: MNH
• UDI-Device Identifier: 10705034788876
• UDI-Public: (01)10705034788876
• 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 Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2018

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: 498.106
• Device Catalogue Number: 498.106
• Device Lot Number: 8241728
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/24/2018
• Supplement Date Received by Manufacturer: 08/30/2018
• Initial Report FDA Received Date: 08/10/2018
• Supplement Report FDA Received Date: 08/31/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR