MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TI DISTRACTION LOCK; PROSTHESIS, RIB REPLACEMENT

Model Number 497.125

Device Problem Break (1069)

Patient Problems Discomfort (2330); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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 Description

It was reported that the patient underwent a revision surgery on (b)(6) 2019 for a failed vertical expandable prosthetic titanium rib (veptr) titanium distal extension, titanium proximal extension and titanium distraction lock, these devices have breakage/fracture.The levels instrumented were t2-pelvic.The patient presented with some discomfort.X-rays revealed splaying of the rails of the proximal extension.The patient also was about to outgrow his extension on the contra-lateral side, so surgery was schedule to replace both sides.There was patient consequence due to myelomeningocele.Procedure outcome is unknown.The patient exposed to additional anesthesia for one (1) hour.Concomitant device reported: unk - rods: spine (part # unknown, lot # unknown # quantity # unknown).This report is for one (1) ti distraction lock.This is report 3 of 3 for complaint (b)(4).

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.The initial complaint was reviewed and found not reportable.The additional information received reasonably suggests that there is no allegation of a complaint against this device and there is no reported malfunction or adverse event caused or contributed to with this device.The device functioned as intended.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: TI DISTRACTION LOCK
• Type of Device: PROSTHESIS, RIB REPLACEMENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8470988
• MDR Text Key: 140537803
• Report Number: 2939274-2019-57213
• Device Sequence Number: 1
• Product Code: MDI
• UDI-Device Identifier: 10705034787480
• UDI-Public: (01)10705034787480
• Combination Product (y/n): N
• PMA/PMN Number: K142587
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 497.125
• Device Catalogue Number: 497.125
• Device Lot Number: H468144
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2019
• Date Manufacturer Received: 04/23/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention