MAUDE Adverse Event Report: SYNTHES (USA) PRODUCTS, LLC ACF SPACER; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Model Number 7MM

Device Problems Crack (1135); Material Fragmentation (1261)

Patient Problem No Code Available (3191)

Event Date 02/01/2016

Event Type  malfunction  

Event Description

Chart reviewed, procedural note states: "we placed a structural allograft into the space with bone in the interbody.Before it was in place, the structural allograft cracked and shattered into pieces.This was discarded due to unsafe use in the patient.We then obtained another structural allograft and tamped it into place, and again this graft shattered into more pieces.Again, this was unsafe for the patient's use.At this point we notified the hospital administration that we would be using the appropriate peek cage to prevent further breakage of structural allograft and to make sure the patient had the best outcome possible.This was absolutely medically necessary at this time.".

• Brand Name: ACF SPACER
• Type of Device: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• Manufacturer (Section D): SYNTHES (USA) PRODUCTS, LLC; 1303 goshen parkway; west chester PA 19380
• MDR Report Key: 5418606
• MDR Text Key: 37732067
• Report Number: 5418606
• Device Sequence Number: 1
• Product Code: MQP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/03/2016,02/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 7MM
• Device Catalogue Number: 017207
• Device Lot Number: 08914038941038
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/03/2016
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 02/03/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 44 YR
• Patient Weight: 85