MAUDE Adverse Event Report: SYNTHES BRANDYWINE TI LUMBAR EXTENSION SIZE 9/220MM RADIUS; PROSTHESIS, RIB REPLACEMENT

Catalog Number 497.134

Device Problem Break (1069)

Patient Problems Failure of Implant (1924); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Device used for treatment, not diagnosis.(b)(4).Device is expected to be returned to synthes manufacturer for evaluation /investigation, but has yet to be received.(b)(4).Without a lot number, the device history record review and 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 Description

Device report from synthes on an event in (b)(6) as follows: it was reported that post-operatively a limb extension rod broke.On (b)(6) 2010, the patient who was suffering thoracic insufficiency syndrome underwent an initial surgery with vertical expandable prosthetic titanium rib (veptr) system.At that time, the fixation was performed at from right rib to lumber with hook, and from right rib to rib.The patient has underwent extension surgery every six months.Half a year ago at the extension surgery, the complained limb extension rod was not exchanged and was still being used because the final fixation surgery is scheduled in (b)(6) 2017.On (b)(6) 2016, the patient went to a hospital and a doctor found the limb extension rod was broken and unhooked at an extension part.On (b)(6) 2016, the patient was hospitalized.On (b)(6) 2016, the revision took place and now at the hospital, the patient is stable condition without pain despite of the implanted the broken rod.The doctor commented that the issue occurred because the limb extension rod in question was extended to the maximum, so it could not tolerate an active child¿s movement.The revision surgery was successful, a new veptr ii was replaced without problem, no patient harm other than revision occured.This complaint involves 1 part.Concomitant devices: 1x 497.125 / 7236511 (closure for extension bar).1x 497.105 / 7352384 (extension bar).This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Concomitant medical product (therapy date): it is unknown when each of the concomitant devices were added to the construct.(b)(6).The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.A review of the device history records has been requested.(b)(6).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

Concomitant devices: closure f/extension bar tan gold (part 497.125, lot 9961805 and 7352384 quantity 2); lock f/rib support tan blue (part 497.128, lot 6882101, quantity 1); closing ½ring f/rib support tan gold (part 497.126, lot 6691726, quantity 1); cranial rib support tan gold (part 497.057, lot 7058425, quantity 1); lam-hook le tan (part 497.261, lot 6114506, quantity 1).This is report 1 of 2 for (b)(4).

Manufacturer Narrative

Device history records review was completed for part# 497.134, lot# 7002891.Manufacturing location: (b)(4), manufacturing date: aug 15, 2012.Component (b)(4) - raw material, lot# 6827057.No nonconforming records were generated during production.No non conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Product investigation was completed for part# 497.134, lot# 7002891.The returned lumbar extension rod is in good condition and shows normal signs of wear and tear.As mentioned in the complaint description the lumbar extension rod was extended to the maximum.This situation in combination with a high load may lead to the fail that occurred.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 LUMBAR EXTENSION SIZE 9/220MM RADIUS
• Type of Device: PROSTHESIS, RIB REPLACEMENT
• Manufacturer (Section D): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer (Section G): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6142305
• MDR Text Key: 61350769
• Report Number: 2520274-2016-15567
• Device Sequence Number: 1
• Product Code: MDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142587
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 497.134
• Device Lot Number: 7002891
• Other Device ID Number: (01)07611819747364(10)7002891
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/15/2012
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 1X 497.105 / (B)(4) (EXTENSION BAR); 1X 497.125 / (B)(4) (CLOSURE FOR EXTENSION BAR)
• Patient Outcome(s): Required Intervention
• Patient Age: 12 YR