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

Catalog Number A1059

Device Problem Mechanical Problem (1384)

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: 3004608878-2019-00219, 3004608878-2019-00220.

Event Description

This is 2 of 3 reports.A customer reported that the locking mechanism of the a1059 mayfield modified skull clamp was very rough; it was not smooth.The date of the event was not specified.According to the customer, they did a preventive maintenance check and there was no patient involvement.Additional information has been requested.

Manufacturer Narrative

Device identifier # 10381780253457.The unit was received with the ratchet extension arm not going through the base smoothly.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 passed all required inspection points with no associated mrr¿s, variances or rework.The reported complaint was confirmed from the evaluation of item.The complaint was likely caused by wear and tear over time.The definite root cause could not be reliably determined.

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: 8925172
• MDR Text Key: 187229087
• Report Number: 3004608878-2019-00221
• 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: 08/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 129
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2019
• Initial Date Manufacturer Received: 08/05/2019
• Initial Date FDA Received: 08/23/2019
• Supplement Dates Manufacturer Received: 09/07/2019
• Supplement Dates FDA Received: 09/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1