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); Device Stops Intermittently (1599); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

This is the second of three reports (same product id, same problem, different clamps).It was reported the swivel base has too much movement when it was locked.Also, the ratchet arm does that ratchet easily; it always stops.There was no patient injury.

Manufacturer Narrative

Integra completed their internal investigation on (b)(6) 2015: methods: evaluation of actual device.Device history record review.Complaint history review.Results: serial number (b)(4): the ratchet extension teeth are damaged, has to be exchanged, furthermore there is a slightly movement in locking mechanism, which has to be overhauled.This device was manufactured on december 31, 2011.A dhr review with lot code 119 showed that the following lots passed all necessary inspection points without any mrrs, reworks or variances.No abnormalities relate to reported incident found nor where there any variances, mrr¿s or reworks associated with this lot/work order number.A two year lookback in trackwise for this reported failure and or related to "too much movement " for this product id shows that (b)(4) complaints were received including this case.No new design or manufacturing trends have been identified.This issue will be monitored.Conclusion: root cause could be normal wear and tear.

• 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
• Manufacturer (Section G): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; cincinnati OH 45227
• Manufacturer Contact: rowena bunuan ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 5050564
• MDR Text Key: 25510035
• Report Number: 3004608878-2015-00234
• 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: foreign
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 08/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2015
• 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: 07/14/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/31/2011
• 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