MAUDE Adverse Event Report: KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG PATIENT CONTOURED MESH - PEEK; BONE PLATE

Model Number 993-03-5721

Device Problems Break (1069); Loose or Intermittent Connection (1371)

Patient Problem No Code Available (3191)

Event Date 08/31/2015

Event Type  Injury  

Manufacturer Narrative

This is one of two related mdr's.Please refer to mdr 9610905-2015-00041.

Event Description

The patient was implanted with a patient-specific kls martin peek implant, fixated by kls martin plates and screws in (b)(6) of 2014.The doctor noted during initial operation the implant was not fitting properly and modified the implant with a burr.Subsequently, the patient complained about the implant being loose, an operation was performed on (b)(6) 2015, and upon re-entry it was determined there were broken fixation plates.The peek implant was intact and unbroken.It is unknown if the fit of the implant, lack of patient compliance, or other unknown factors were cause of the broken fixation plates.

Manufacturer Narrative

The device was optically assessed and tested against the skull model.The device fit properly in the model.In addition, there were no indications of material or manufacturing defects discovered.The material and device history records were reviewed based on the lot number provided and no abnormalities were detected.The results of the investigation conclude that the root cause for implant loosening is unknown and cannot be ascertained.If further information can be gathered that can add value to the contents of the investigated report, an additional follow-up report will be submitted.

• Brand Name: PATIENT CONTOURED MESH - PEEK
• Type of Device: BONE PLATE
• Manufacturer (Section D): KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG; kolbinger strabe 10; muhlheim/donau, 78577 0; GM 785770
• Manufacturer (Section G): KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG; kolbinger strabe 10; muhlheim/donau, 78570 ; GM 78570
• Manufacturer Contact: jennifer damato ; p.o. box 16369; jacksonville, FL 32245 ; 9046417746
• MDR Report Key: 5108343
• MDR Text Key: 26906119
• Report Number: 9610905-2015-00048
• Device Sequence Number: 1
• Product Code: GXN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072707
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 09/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 993-03-5721
• Device Lot Number: SSR 0356
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/01/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other