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

Catalog Number A1059

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/15/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

An integra technical service analyst reported that an a1059 mayfield modified skull clamp base casting was cracked at the floating ratchet opening.The date of the event was not specified.It was unknown if there was patient contact, injury, or surgery delay.Additional information was received from the customer on (b)(6) 2019 indicating that on (b)(6) 2019 a crack was found on the mayfield skull clamp after being removed from a (b)(6) year old male patient's head at the end of surgical procedure.There was no patient injury reported.

Event Description

N/a.

Manufacturer Narrative

The device was returned for evaluation and it was received with the base casting cracked at the floating ratchet opening; the base will need to be replaced.The lock has both rotational and lateral movement and a residue buildup was present.Upon disassembly, repair noted the index knob and the lock will need new components added to replace worn internal parts; the setscrew in the swivel base was tight.The device history record showed that this device exceeded its expected life of 7 years.The reported complaint was confirmed.Because of extended use, the most likely root cause was wear and tear.

• 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: 8326535
• MDR Text Key: 137440741
• Report Number: 3004608878-2019-00031
• 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
• Report Date: 01/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A1059
• Device Lot Number: 024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2019
• Date Manufacturer Received: 02/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 50 YR