MAUDE Adverse Event Report: SYNTHES, INC; S HOOK

Model Number 04.601.00

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 08/07/2015

Event Type  malfunction  

Event Description

Patient had an implantation of vertical expandable prosthetic titanium ribs, ribs to pelvis devise which was changed to a rib to lamina device 2 years ago, and back to a rib to pelvis device.Upon x-rays for preop of her surgery it was noted that the pelvic hook had broken.Patient underwent a right pelvic hook replacement and revision with right titanium rib device expansion.

• Type of Device: S HOOK
• Manufacturer (Section D): SYNTHES, INC; west chester PA 19380
• MDR Report Key: 5067745
• MDR Text Key: 25506527
• Report Number: MW5056071
• Device Sequence Number: 1
• Product Code: MDI
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Report Date: 09/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 04.601.00
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 10 YR
• Patient Weight: 22