MAUDE Adverse Event Report: AESCULAP AG AND CO. KG HYDROLIFT VBR SZ.6 (57-93.5MM)/ENDPL.L; VERTEBRAL BODY REPLACEMENT

Model Number SV018T

Device Problem Inflation Problem (1310)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

Country of complaint: (b)(6).During corporectomy lwk 2 and 3 the surgeon tried to distract the hydrolift sv018t with an fw450su / hydrolift hydraulic applicator.At 26 bar, pressure the connection tube burst.Surgeon obtained a second fw450su, the connection bursts again, at 25 bar.Implant was removed and tested with a third fw450su outside the body.On the first 10mm they noticed a slip stick effect, then the hydrolift distracted without problems.Tested outside until 20 bar.Surgeon implanted the hydrolift again and tried the distraction again.Luerlock connector bursts at 24 bar.Some of the nacl solution sprayed up on the unsterile luminaire and dripped into the pt.The trial to distract the hydrolift manually miscarried.Surgeon explanted the hydrolift and used an ullrich obelisk successfully.The pt was given 7 days of antibiotics.

Manufacturer Narrative

Us reporting agent notified on (b)(4) 2014.Manufacturing site evaluation: visual inspection: the hydrolift arrived decontaminated without original box.The implant exhibits no damages.Distraction test: tested the implant with an merit blue diamond inflation device.Result: up to 30 bar, the hydrolift shows no leakage.No abnormality (such as sticking) was noted.Conclusion: the described error could not be detected, the implant works without any abnormality, no failure could be found.

• Brand Name: HYDROLIFT VBR SZ.6 (57-93.5MM)/ENDPL.L
• Type of Device: VERTEBRAL BODY REPLACEMENT
• Manufacturer (Section D): AESCULAP AG AND CO. KG; tuttlingen DE 78532
• Manufacturer (Section G): AESCULAP AG AND CO KG; po box 40; tuttlingen 7850 1; GM 78501
• Manufacturer Contact: michelle link ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515938
• MDR Report Key: 4359487
• MDR Text Key: 5113914
• Report Number: 3005673311-2014-00091
• Device Sequence Number: 1
• Product Code: MQP
• Combination Product (y/n): N
• PMA/PMN Number: K083186
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Type of Report: Initial
• Report Date: 11/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2016
• Device Model Number: SV018T
• Device Catalogue Number: SV018T
• Device Lot Number: 51746211
• Date Manufacturer Received: 04/24/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other