MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD COMPOSITE SERIES SKULL CLAMP; ¿COMPOSITE SERIES¿

Catalog Number A3059

Device Problem Device Slipped (1584)

Patient Problem Laceration(s) (1946)

Event Date 10/26/2022

Event Type  Injury  

Event Description

This is 1 of 2 reports linked to mfg report #: 3004608878-2022-00249.A facility reported that the mayfield composite skull clamp (a3059) and the mayfield base unit (a3101) was used for cranial stabilization during a "suboccipital craniotomy for tumor." the surgeon was positioning the patient in prone into skull clamp and preparing the surgical field when a clicking sound was heard but it was not clear where the sound was coming from.The surgeon felt that the screw was not tensioning adequately and that it slipped during procedure.This resulted in a 4cm laceration from the skull pin to the rear of the patient's skull which was closed with sutures.After the case, the surgeon commented that the screw had again come loose in its tensioning.Surgery was delayed for 15 minutes.

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

N/a.

Manufacturer Narrative

Updated fields: d4, d9, g4, g6, h2, h3, h4, h6, h10 the mayfield composite series skull clamp (a3059) was returned for evaluation: device history record (dhr): the dhr was reviewed and shows no abnormalities related to the reported failure.Failure analysis: evaluation found no device deficiencies that would have contributed to the reported complaint of "slippage." they were unable to duplicate slippage.However, unit needed basic preventive maintenance from routine use.Root cause: the complaint is not confirmed via inspection of the unit.Probable root cause of the reported complaint is improper or suboptimal placement of the mayfield system.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

• Brand Name: MAYFIELD COMPOSITE SERIES SKULL CLAMP
• Type of Device: ¿COMPOSITE SERIES¿
• 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: 15829067
• MDR Text Key: 303957118
• Report Number: 3004608878-2022-00248
• Device Sequence Number: 1
• Product Code: HBL
• Combination Product (y/n): N
• PMA/PMN Number: K142238
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/27/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: A3059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/28/2022
• Initial Date FDA Received: 11/18/2022
• Supplement Dates Manufacturer Received: 01/19/2023
• Supplement Dates FDA Received: 01/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/18/2018
• 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
• Treatment: A3101 MAYFIELD BASE UNIT (SN: (B)(4))
• Patient Age: 69 YR
• Patient Sex: Female