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

Catalog Number A1059

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The device was not yet 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.Linked to mfg report number: 3004608878-2019-00176 and 3004608878-2019-00177.

Event Description

This is 1 of 3 reports.A sales representative reported on behalf of the customer that the a1059 mayfield modified skull clamp locking knob was broken.Received additional information from customer on 26jun2019 that the device was no patient contact, injury or delay in surgery.The customer noticed the issue during regular mayfield inspections.Additional information has been requested.

Manufacturer Narrative

The unit was received with the lock has rotational and lateral movement and a residue buildup was present.The unit needed new components added to replace worn internal parts; general maintenance and cleaning required.The device history record review showed no abnormalities related to the reported failure.The device manufactured passed all required inspection points with no associated mrr¿s, variances or rework.The complaint was confirmed.The likely cause for worn parts and buildup is wear and tear.Device identifier (b)(4).

Event Description

N/a.

• 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: 8793452
• MDR Text Key: 151127997
• Report Number: 3004608878-2019-00175
• 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: 06/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2019
• 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: 149
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2019
• Date Manufacturer Received: 08/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1