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

Model Number	121-100-50
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No evaluation possible at this time.The instrument has not been returned.
Event or Problem 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
• Common Device Name: MAX
• Manufacturer (Section D): ALPHATEC SPINE INC; 5818 el camino real; carlsbad, ca
• MDR Report Key: 10431171
• Report Number: 2027467-2020-00035
• Device Sequence Number: 16949204
• Product Code: MAX
• UDI-Device Identifier: 00190376204765
• UDI-Public: (01)00190376204765
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: 121-100-50
• Device Catalogue Number: 121-100-50
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/24/2020
• Initial Report FDA Received Date: 08/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization