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	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device history record (dhr): the dhr shows no abnormalities related to the reported failure.The mayfield spine table adaptor (a2600m) was returned for evaluation.With respect to the complaint, it was confirmed the returned unit did not meet all specific functional test.The right bracket knob is grinding when tightened.The evaluation showed that the base handle is out of adjustment and not holding properly; the shock cushion is worn.The unit needs repair, and replacement of worn parts.General maintenance and cleaning required.No further investigation required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.
Event or Problem Description
A facility reported that the gold handle on the mayfield spine table adaptor metal (a2600m) would not lock securely.It is unknown if there was patient involvement; however, no patient injury or surgical delay has been reported.

• 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
• MDR Report Key: 12009243
• Report Number: 3004608878-2021-00415
• Device Sequence Number: 14611740
• 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: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• 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
• 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: 06/02/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/26/2021
• Initial Report FDA Received Date: 06/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1