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

Catalog Number A1059

Device Problem Physical Resistance/Sticking (4012)

Patient Problem No Known Impact Or Consequence To Patient (2692)

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

It was reported that the a1059 mayfield modified skull clamp, the ratcheting mechanism was sticking.It is unknown if there was any patient contact or injury.Additional information has been sent.

Manufacturer Narrative

The device was returned for evaluation.No dhr review was possible as the provided serial number (b)(6) does not appear to be valid integra identification number.The unit was received having both rotational and lateral movement and a buildup of residue.Upon disassembly, it was noted that the index knob and lock needed new components to replace worn internal parts.Index knob is old and needs to be updated.Unit needs to be machined to have heli-coils added to the large starburst threads.The set screw in the swivel base was tight.The reported complaint was confirmed via inspection of the unit.The lock is difficult to turn and sticking due to heavy residue build up in the locking mechanism.Udi # (b)(4).

• 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: 10283158
• MDR Text Key: 203675520
• Report Number: 3004608878-2020-00120
• 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: consumer,user facility
• Type of Report: Initial,Followup
• Report Date: 02/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2020
• 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: 02/12/2020
• Date Manufacturer Received: 04/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1