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

Catalog Number A1059

Device Problems Device Slipped (1584); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Laceration(s) (1946)

Event Type  Injury  

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 during placement of the mayfield modified skull clamp (a1059), a patient laceration occurred.Additional information regarding the event, patient injury and surgical delay has been requested.

Manufacturer Narrative

Updated fields: d4 (udi #), d9, g3, g6, h2, h3, h6, h10.Corrected field: d4 (serial number).The mayfield modified skull clamp (a1059) was returned for evaluation: failure analysis: the investigation did not conclusively confirm the issue of "slippage" reported by the customer.However, unrelated to the reported alleged failure, the unit received had a crack in the large starburst, and the lock had lateral and rotational movement due to residue build up in the lock.All worn components replaced with new components.General maintenance and cleaning required at this time.To resolve these issues, the base casting and all worn components were replaced.Root cause: evaluation found no device deficiencies that would have contributed to the reported complaint.Repairs could not duplicate slippage.Probable root cause for reported incident is improper placement of the skull clamp.No further investigation required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.Unit is beyond integra's 7 years recommended life cycle (manufactured in 2010).

Event Description

N/a.

Manufacturer Narrative

Medwatch uf/ importer report # (b)(4) was received on 28sept2021 with the following information: "while patient was laying on cart, neuro resident pinned patient's head using mayfield c clamp, while positioning patient prone on jackson spine table.While neuro resident was holding onto the mayfield c clamp, he felt it slip and laceration was discovered.Patient was then repositioned back onto cart, surgeon staff made aware.Laceration was noted on left parietal area about 2 cm long.Area was cleaned, and stapled.A new mayfield c clamp was put on patient, and the first was cleaned, bagged, and given to neuro coordinator." the original intended procedure was c5-7 laminoplasty.

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
• MDR Report Key: 12356524
• MDR Text Key: 267823441
• Report Number: 3004608878-2021-00532
• 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,Followup
• Report Date: 10/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: A1059
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/09/2021
• Initial Date Manufacturer Received: 07/30/2021
• Initial Date FDA Received: 08/23/2021
• Supplement Dates Manufacturer Received: 09/08/2021; 09/28/2021
• Supplement Dates FDA Received: 09/22/2021; 10/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 76