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

Catalog Number A1059

Device Problem Device Slipped (1584)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/06/2019

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to the manufacturer for analysis.The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.

Event Description

Initially the customer reported patient injury during a slip with the a1059 mayfield modified skull clamp on (b)(6) 2019.Additional information received on 09dec2019 reported that the pins moved during the transfer of the patient to the surgical bed, before a spinal,procedure.There was no laceration, the patient was fine.The action that was taken when the product problem occurred was that a replacement product was used.There was a 10-minute surgical delay without any patient consequences.

Event Description

N/a.

Manufacturer Narrative

The device was returned for evaluation.Dhr review is not possible, no lot or serial number was provided during the course of the complaint investigation.Complaint not confirmed, as the product passed all visual inspections and functional tests.The lock had rotational and lateral movement in the unlocked position; however, in the locked position the lock did not move and functioned as intended.Lock had buildup and residue.The unit functions as intended.

• 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: 10277070
• MDR Text Key: 203531322
• Report Number: 3004608878-2019-01132
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 12/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A1059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2019
• Date Manufacturer Received: 03/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SKULL PINS.