MAUDE Adverse Event Report: AESCULAP AG 6 CRANIOFIX ABSORBABL.CLAMP STERILE 11MM; RESORBABLE IMPLANTS

Model Number FF016

Device Problem Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/04/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: on-going.

Event Description

Country of complaint: (b)(6).Thread sheared off of screw intra-operatively.The thread broke at the level of the disk so the application of the clamp was no longer possible, the clamp was replaced.Surgery was delayed over 15 minutes; no patient injury reported.

• Brand Name: 6 CRANIOFIX ABSORBABL.CLAMP STERILE 11MM
• Type of Device: RESORBABLE IMPLANTS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 5495862
• MDR Text Key: 40182161
• Report Number: 2916714-2016-00189
• Device Sequence Number: 1
• Product Code: GXR
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K040080
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: FF016
• Device Catalogue Number: FF016
• Device Lot Number: 52147815
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2016
• Distributor Facility Aware Date: 03/04/2016
• Date Manufacturer Received: 02/12/2016
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other