FDA Adverse Event Injury Summary report: N

PROSTHESIS, RIB REPLACEMENT

MDR report key: 3802527 · Received May 9, 2014

Report

Report Number: 2520274-2014-11376
Event Type: Injury
Date Received: May 9, 2014
Report Date: March 9, 2014
Manufacturer: SYNTHES USA
Product Code: MDI
PMA / PMN Number: PH030009
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MI, US
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

THIS DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. (B)(6). DATE OF EVENT UNKNOWN THIS REPORT IS FOR ONE UNKNOWN DISTAL EXTENSION. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. MANUFACTURING RECORDS COULD NOT BE REVIEWED WITHOUT A LOT NUMBER. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

Description of Event or Problem · 1

IT WAS REPORTED A REVISION SURGERY WAS PERFORMED DUE TO A TITANIUM PARALLEL CONNECTOR THAT BECAME LOOSE ON THE ROD. THE PATIENT WAS ORIGINALLY TREATED WITH A VERTICAL EXPANDABLE PROSTHETIC TITANIUM RIB AT T3 TO THE PELVIS FOR SCOLIOSIS ON (B)(6) . ON AN UNKNOWN DATE, THE PATIENT¿S MOTHER DISCOVERED THAT THE PATIENT¿S BACK WAS NOT NEUTRAL. THE PATIENT VISITED THE SURGEON ON AN UNKNOWN DATE AND IT WAS CONFIRMED VIA CT SCAN THAT THE PARALLEL CONNECTOR LOOSENED FROM THE S-HOOK TO THE DISTAL EXTENSION. IT WAS REPORTED THAT THE SURGEON STATED THAT THE CONNECTOR WAS NOT TIGHT ENOUGH. THE SURGEON REPLACED THE LOOSENED CONNECTOR AND SURGERY WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE UNKNOWN DISTAL EXTENSION. THIS REPORT IS 3 OF 3 FOR (B)(4).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
281832		PROSTHESIS, RIB REPLACEMENT	MDI	SYNTHES USA

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention