MAUDE Adverse Event Report: ALPHATEC SPINE INC IDENTITI POSTERIOR STRAIGHT POROUS TI INTERBODY SYATEM; MAX

Model Number 121-100-50

Device Problems Break (1069); Material Twisted/Bent (2981)

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

Event Type  Injury  

Manufacturer Narrative

No evaluation possible at this time.The instrument has not been returned.

Event Description

It appears that the inserter sleeve on the identiti ps inserter bent in-situ and caused the ps implant to break.An additional cage had to places in the disk space causing over a 30 minute delay in the case.

• Brand Name: IDENTITI POSTERIOR STRAIGHT POROUS TI INTERBODY SYATEM
• Type of Device: MAX
• Manufacturer (Section D): ALPHATEC SPINE INC; 5818 el camino real; carlsbad, ca
• Manufacturer Contact: richard younger ; 5818 el camino real; carlsbad, ca ; 4949286
• MDR Report Key: 10431171
• MDR Text Key: 203986572
• Report Number: 2027467-2020-00035
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 00190376204765
• UDI-Public: (01)00190376204765
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 121-100-50
• Device Catalogue Number: 121-100-50
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/24/2020
• Initial Date FDA Received: 08/20/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization