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

Catalog Number XXX-MAYFIELD SKULL CLAMP

Device Problem Device Slipped (1584)

Patient Problem Laceration(s) (1946)

Event Date 05/21/2021

Event Type  Injury  

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

Medwatch form uf/ importer report # (b)(4) was received on 28oct2021 with the following information: 'patient's head slipped in mayfield head pins.Mayfield with skull pins was applied to patient's head, then patient was positioned prone on wilson frame on or bed and shoulders taped torse foot of bed.While doing x-ray to check for position, surgeon noticed that the skull pin on left temporal had moved and was bleeding.Patient put back on stretcher.Mayfield removed and skin staples applied to laceration.A second laceration was also noticed that was also closed with staples.During positioning (prior to incision), mayfield head positioner slipped (ratchets loosened and was unrecognized).Patients head slipped out of pegs and sustained 2 lacerations in scalp requiring stapling." additional information received from customer as follows: the delay to incision start time was over 30 min, as the lacerations needed to be addressed and repositioning completed.The skull pins used were integra disposable skull pins (a1072), and the patient outcome was recorded as stable per final note.Additionally, customer has responded that there is no ¿product id¿ on the device as it is a piece of positioning equipment, neither is there a lot/serial number for the involved device.

Manufacturer Narrative

The mayfield skull clamp was not returned for evaluation after three good faith attempts (gfes) were made.Lot number information has not been provided; therefore, an evaluation of the device could not be performed, and device history records (dhr) could not be reviewed.The definite root cause(s) cannot be identified; however, a probable root cause for the reported complaint is improper positioning of the skull clamp on the patient.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.

Event Description

N/a.

• Brand Name: UNKNOWN MAYFIELD SKULL CLAMP
• Type of Device: SKULLCLAMPS 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: 12845045
• MDR Text Key: 281028655
• Report Number: 3004608878-2021-00635
• Device Sequence Number: 1
• Product Code: HBL
• 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: Other,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/20/2022

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: XXX-MAYFIELD SKULL CLAMP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/28/2021
• Initial Date FDA Received: 11/19/2021
• Supplement Dates Manufacturer Received: 01/06/2022
• Supplement Dates FDA Received: 01/20/2022
• 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
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 94 KG
• Patient Race: White