MAUDE Adverse Event Report: SYNTHES BRANDYWINE TI LUMBAR EXTENSION SIZE 13/220MM RADIUS; PROSTHESIS, RIB REPLACEMENT

Catalog Number 497.254

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Type  malfunction  

Event Description

During a routine examination of patient with vertical expandable prosthetic titanium rib (veptr) construct in place, it was noted that the right inferior rod was broken at the junction between the rod and male extension.Patient was scheduled for definitive fusion; veptr construct was removed and patient received definitive fusion as planned without incident.The surgery was successfully completed.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

The investigation could not be completed; no conclusion could be drawn, as no product was received.A device history review was conducted.The report indicates that for part # 497.254, lot# 4833047 indicate that the reported product was manufactured at the (b)(4) manufacturing facility on 12/13/2004 under work order 838478.Dhr records indicate that the product lot was manufactured in accordance with all established requirements with no nonconformities reported.Dhr records for part # 497.254, lot# 4833047 further indicates that the product lot underwent all specified inspection requirements with no product nonconformities reported.Dhr records for p/n 497.254, lot# 4833047 indicate that the product lot was produced from raw material tialnbfi120.00x18.00, p/n 24019, lot# 4772776 in accordance with established specifications.Dhr records for raw material tialnbfi120.00x18.00, p/n 240195, lot# 4772776 indicate that the raw material was received at the (b)(4) facility on 10/04/2004 and released to inventory on 10/04/2004.Dhr records for the raw material lot further indicate that the raw material underwent all specified inspection and testing requirements and was found to meet all established criteria for acceptance and use as intended.There is no objective evidence within the dhr for the reported product indicating that its manufacturing processes contributed to the reported complaint category - product related, synthes: broken : postoperatively.(b)(4).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 13/220MM 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: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4268984
• MDR Text Key: 5028720
• Report Number: 2530088-2014-10386
• Device Sequence Number: 1
• Product Code: MDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PH030009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 10/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 497.254
• Device Lot Number: 4833047
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/29/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2004
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Weight: 52