MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD MODIFIED SKULL CLAMP; SKULL CLAMPS AND HEADREST SYSTEMS

Model Number A1059

Device Problem Device Slipped (1584)

Patient Problem Laceration(s) (1946)

Event Type  Injury  

Manufacturer Narrative

Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

A facility reported that the mayfield modified skull clamp (a1059) slipped and caused a patient laceration.No surgical delay has been reported.Additional information has been requested.

Manufacturer Narrative

Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h10 mayfield modified skull clamp (a1059) was returned for evaluation.Device history record (dhr): the dhr was reviewed and shows no abnormalities related to the reported failure.Failure analysis -upon investigation of the returned unit, it was noted that the returned unit had only slight movement in the lock, but when properly positioned and put under pressure, it did not move.A residue buildup was present on inspection, and on disassembly, it was noted that the index knob and the lock would need new components added to replace worn internal parts.The unit was also machined to have heli coils added to large starburst threads.Root cause - the complaint of slippage could not be confirmed via inspection and testing of the unit.When properly positioned with pressure applied, the unit performed without failure.The device was cleaned, machined, with routine maintenance performed, and any worn internal components replaced.No further investigation is required based on the acceptability of risk and no adverse trends were identified.This will be monitored and trended going forward.At present, we consider this complaint to be closed.

Event Description

N/a.

• Brand Name: MAYFIELD MODIFIED SKULL CLAMP
• Type of Device: SKULL CLAMPS AND HEADREST SYSTEMS
• 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: 16065317
• MDR Text Key: 306315971
• Report Number: 3004608878-2022-00288
• Device Sequence Number: 1
• Product Code: HBL
• UDI-Device Identifier: 10381780253457
• UDI-Public: 10381780253457
• Combination Product (y/n): N
• PMA/PMN Number: PRE-AMEND
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: A1059
• Device Catalogue Number: A1059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/09/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1