MAUDE Adverse Event Report: ADVANCED MEDICAL TECHNOLOGIES DISTRACTABLE WAVE CAGE; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Catalog Number WD-09.24.6

Device Problem Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/26/2014

Event Type  malfunction  

Manufacturer Narrative

The device has been returned to the manufacturer for evaluation.Multiple cracks emanating from the threaded hole are noted, with one arm of the implant nearly broken in half.The above observations are consistent with brittle overload.

Manufacturer Narrative

(b)(6).(b)(4).Analysis results are not available at the time of this report.A follow-up report will be sent when the analysis is complete.

Event Description

It was reported that during the posterior lumbar interbody fusion (plif) the cage cracked after being hit one time with the mallet.There were no patient complications reported.

• Brand Name: DISTRACTABLE WAVE CAGE
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): ADVANCED MEDICAL TECHNOLOGIES; kasteler str. 11; nonnweiler 66620
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• Manufacturer Contact: huzefa mamoola ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 3701222
• MDR Text Key: 11929458
• Report Number: 3003529816-2014-00008
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083626
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: WD-09.24.6
• Device Lot Number: 13038A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/27/2014
• Initial Date FDA Received: 03/26/2014
• Supplement Dates Manufacturer Received: Not provided; 05/27/2014
• Supplement Dates FDA Received: 06/24/2014; 09/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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