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

Catalog Number A1059

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/28/2020

Event Type  malfunction  

Manufacturer Narrative

Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

A facility reported that the rotation lock of the mayfield skull clamp loosened multiple times while the surgeon was attempting to position the patient, causing the patient's head to move unexpectedly.The skull clamp was adjusted and tightened multiple times before it stayed in place as it is intended to.There was an unspecified delay in surgery with no patient injury reported.Additional information has been requested.

Event Description

N/a.

Manufacturer Narrative

Udi: (b)(4).Device history record (dhr) - the dhr shows no abnormalities related to the reported failure.Mayfield skull clamp (a1059) was returned for evaluation.Upon evaluation, unit was found out to have lateral and rotational movement.It has also some residue build up and worn parts and needs preventative maintenance, repair and replacement of worn parts.The reported complaint was confirmed.No further investigation required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.

• 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: 11060705
• MDR Text Key: 226090181
• Report Number: 3004608878-2020-00753
• Device Sequence Number: 1
• Product Code: HBL
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/30/2020

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2021
• Initial Date Manufacturer Received: 11/30/2020
• Initial Date FDA Received: 12/22/2020
• Supplement Dates Manufacturer Received: 01/27/2021
• Supplement Dates FDA Received: 02/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1