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

Catalog Number	A2600M
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/16/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
This is 1 of 2 reports linked to mfg report number 3004608878-2024-00033: a facility reported that during an unspecified case, the mayfield spine table adaptor metal (a2600m) slipped, resulting in injury to the patient.Additional information has been requested.
Additional Manufacturer Narrative
The mayfield spine table adaptor metal (a2600m) was returned for evaluation: device history record (dhr) - the dhr was reviewed and shows no abnormalities related to the reported failure.Failure analysis -evaluation of the returned unit was unable to duplicate slippage; the handle locks into position and holds up to 30ft.Lbs.Without slipping.However, the unit is nearly 3 years old and has never been serviced; therefore, it is recommended that the unit receive preventive maintenance (pm).To resolve wear issues found, the 6in transitional, shock cushion and label will be replaced along with general cleaning and maintenance performed.Further, the unit was sent to quality engineering for further investigation due to reported injury, and the initial findings were confirmed by quality engineering (unit was in worn condition with wear/cosmetic damage visible on the unit).No additional device deficiencies were observed.Root cause - evaluation found no device deficiencies that would have contributed to the reported complaint as slippage could not be duplicated.Probable root cause of the reported complaint is improper or suboptimal placement of the skull clamp on the patient.No further investigation is required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.At present, we consider this complaint to be closed.

• 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: 18894988
• Report Number: 3004608878-2024-00032
• Device Sequence Number: 7514731
• 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): 03/13/2024

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: A2600M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/19/2024
• Initial Report FDA Received Date: 03/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/23/2020
• 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