MAUDE Adverse Event Report: ALPHATEC SPINE, INC. LIF-PTP; KEYED BEDRAIL CLAMP

Model Number	300-351
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned for evaluation.The root cause is unable to be determined at this time.If any additional information is provided, a supplemental report will be submitted.
Event or Problem Description
During the ptp portion of the procedure, the a-arm was incapable of loading into the bedrail clamp, causing a delay in the case.A lif clamp was able to be unitized which allowed the case to proceed.No patient injury reported.
Additional Manufacturer Narrative
H6: medical device problem: 2306 medical device component: 757 type of investigation: 3331; 4114 investigation findings: 4245 investigation conclusion: 27 h10: the report indicates the incorrect bedrail clamp ((b)(4).) was received in set ptparm26.This caused a delay in surgery.There was no report of device malfunction or patient injury.Set ptparm26 returned to atec with the correct bedrail clamp (pn (b)(4).Ln 8679401).(b)(4).Did not return with the set.Photographs were not provided to confirm the event.A review of complaint records indicates this is the only report of incorrect bedrail which caused a delay in surgery.The root cause cannot be determined but may be the result of a processing error.

• Brand Name: LIF-PTP
• Common Device Name: KEYED BEDRAIL CLAMP
• Manufacturer (Section D): ALPHATEC SPINE, INC.; 1950 camino vida roble; carlsbad CA 92008
• Manufacturer Contact: jayson alaba ; 1950 camino vida roble; carlsbad, CA 92008 ; 7604946771
• MDR Report Key: 12174351
• Report Number: 2027467-2021-00047
• Device Sequence Number: 1480408
• Product Code: CCX
• UDI-Device Identifier: 00190376307169
• UDI-Public: 00190376307169
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2021

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 Model Number: 300-351
• Device Catalogue Number: 300-351
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/15/2021
• Supplement Report FDA Received Date: 12/14/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown