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

Catalog Number A1059

Device Problems Mechanical Problem (1384); Material Integrity Problem (2978)

Patient Problems Laceration(s) (1946); Injury (2348)

Event Date 11/06/2020

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 customer reported that the shunt came out of the package of the mayfield modified skull clamp (product id a1059) misshaped.Additionally, no delay in surgery was reported, but it was reported that the device was in contact with the patient and an unspecified patient injury occurred.Additional information has been requested.

Manufacturer Narrative

Unique device identifier (udi): (b)(4).Mayfield skull clamp (a1059) was not returned for evaluation (as per customer, product not available) and lot number information has not been provided; therefore, an evaluation of the device could not be performed, and manufacturing records could not be reviewed.The cause(s) of the difficulty reported by the customer could not be determined.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.

Event Description

N/a.

Manufacturer Narrative

Additional information received states that the information in the detail section is incorrect, it is not a shunt complaint, and the complaint description should be revised to the following: skull clamp did not maintain torque pressure and clamp needs to be replaced due to age.Further information was also received from the customer indicating that the silver mayfield clamp attachment was being used to hold patient's head in pins for a cervical spine procedure.The clamp did not hold and the patient's head slipped requiring stitches to repair the laceration on the side of the head.The patient did not die but a laceration was sustained.There was no delay in surgery or treatment.

• 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 45227
• MDR Report Key: 10930295
• MDR Text Key: 219142867
• Report Number: 3004608878-2020-00711
• 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: company representative,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 11/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: A1059
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1