MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD SPINE TABLE ADAPTOR METAL; BASE UNITS AND ADAPTERS

Model Number	A2600M
Medical Device Problem Code	Mechanics Altered (2984)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2021
Type of Reportable Event	Malfunction
Event or Problem Description
This is 2 of 2 reports linked to mfg report number 3004608878-2021-00706: a facility reported that when patient was put in pins with mayfield skull clamp and the mayfield spine table adaptor base unit (a2600m), the patient moved during the procedure as the patient¿s positioning changed.The handle¿s releasing lever is very loose, and thought to be the issue.The customer sent in both units for further inspection due to the incident.No patient injury or surgical delay has been reported.
Additional Manufacturer Narrative
The mayfield spine table adaptor base unit (a2600m) was returned for evaluation: device history record (dhr): the dhr was reviewed and no anomalies that could be associated with the complaint incident was observed.Failure analysis: the investigation of the returned device showed that the shock cushion was replaced due to it moving out of position and impeding the 6-inch transitional.Unit received with an older transitional than the one that was issued with the repair.The 6in transitional will not be replaced since the hospital already has a new one on hand.General maintenance and cleaning has been performed.Root cause: complaint confirmed via inspection of the unit.The shock cushion had moved out of position in the handle and was impeding the 6-inch transitional, the shock cushion was replaced.No further investigation required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.

• Brand Name: MAYFIELD SPINE TABLE ADAPTOR METAL
• Common Device Name: BASE UNITS AND ADAPTERS
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; 4900 charlemar drive; cincinnati OH
• Manufacturer (Section G): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; cincinnati OH
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 13061992
• Report Number: 3004608878-2021-00707
• Device Sequence Number: 3951123
• Product Code: FWZ
• UDI-Device Identifier: 10381780268062
• UDI-Public: 10381780268062
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/22/2021

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
• Operator of Device: Health Professional
• Device Model Number: A2600M
• Device Catalogue Number: A2600M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/30/2021
• Initial Report FDA Received Date: 12/22/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/28/2011
• 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