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

Catalog Number A1059

Device Problem Device Slipped (1584)

Patient Problem Laceration(s) (1946)

Event Date 07/28/2023

Event Type  Injury  

Event Description

A facility reported that the mayfield modified skull clamp (a1059) was installed in supine, tightened at position 3,5.The patient was returned and after reversal, when they wanted to fixed the skull clamp on the support, there was slippage of the head inside the "arc" with skull clamp tightened at position 0,5.The patient had wound on the scalp, and a 2nd device was used to complete the procedure.No delay was reported.

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Manufacturer Narrative

Updated fields: d4, d9, g3, g6, h2, h3, h6, h10 mayfield modified skull clamp (a1059) was returned for evaluation: failure analysis - investigation of the returned unit showed that the unit had a sticking swivel lock assembly, and a residue buildup was present.Some worn off internal parts were required to adjust the swivel lock assembly, along with general maintenance and cleaning.To resolve all issues, the base was replaced along with the required internal parts, and the swivel lock assembly was assembled and adjusted.A successful function test was performed and the unit was marked.Root cause - the complaint is confirmed via inspection of the unit.The unit required replacement of worn internal parts and the base casting was replaced due to worn starburst teeth.Probable root cause is routine use and wear.Additionally, improper or suboptimal placement of the skull clamp can contribute to movement or slippage of the patient.No further investigation is required based on the acceptability of risk and no adverse trends were identified.This will be monitored and trended going forward.At present, we consider this complaint to be closed.

Event Description

N/a.

Manufacturer Narrative

Additional information received indicating the following: patient : female / 44 years old.Type of surgery : cranial intervention on the occipito-cervical hinge (type ¿arnold chiari¿) mayfield was tightened at position 3.5 / prone positioning of the patient when turning the patient, the head and the skull clamp were maintained by the surgeon.The skull clamp did not tighten leading to wound of the scalp (left side / around 5 cm) a suture of the subskin was necessary as well as the installation of staples on the skin.Surgery time was increased: time for suture / installation of new skull clamp and then returning so around 30 minutes before beginning the surgery.The patient is doing well.Healing of the wound is in progress.

• 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
• Manufacturer (Section G): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; cincinnati OH
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 17619476
• MDR Text Key: 321926187
• Report Number: 3004608878-2023-00156
• Device Sequence Number: 1
• Product Code: HBL
• UDI-Device Identifier: 10381780253457
• UDI-Public: 10381780253457
• 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: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/13/2023

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: A1059
• Device Lot Number: RLU0239
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/24/2023
• Supplement Dates Manufacturer Received: 09/15/2023; 10/05/2023
• Supplement Dates FDA Received: 10/02/2023; 10/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 44 YR
• Patient Sex: Female