MAUDE Adverse Event Report: KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG LEVEL ONE THORACIC; SCREW

Model Number 24-015-25-71

Device Problem Failure to Osseointegrate (1863)

Patient Problems Impaired Healing (2378); Inadequate Osseointegration (2646)

Event Date 03/15/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: mdr 9610905-2018-00044 and mdr 9610905-2018-00045.

Event Description

It was reported a screw was implanted into the patient's cartilage instead of the bone causing a portion of the plate to be mobile from lack of fixation.All product was removed and replaced due to placement.

Manufacturer Narrative

An investigation was performed on the basis of complaint statistics as no device was returned for evaluation.The complaint percentage falls within the design risk limits adhered to at klm.The review of the device history records was not possible due to no lot number being identified.Due to no device being returned the root cause for the failure cannot be determined.If further information is obtained that might add value to the contents of the investigation report, an additional follow-up report will be submitted.

• Brand Name: LEVEL ONE THORACIC
• Type of Device: SCREW
• Manufacturer (Section D): KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG; kolbinger strabe 10; muhlheim/donau, 78570 ; GM 78570
• 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: 7424570
• MDR Text Key: 105243744
• Report Number: 9610905-2018-00046
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 10888118011364
• UDI-Public: (01)10888118011364
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153482
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/15/2018

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: Physician
• Device Model Number: 24-015-25-71
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/15/2018
• Initial Date Manufacturer Received: 03/15/2018
• Initial Date FDA Received: 04/12/2018
• Supplement Dates Manufacturer Received: 06/29/2018; 06/29/2018
• Supplement Dates FDA Received: 10/03/2018; 07/25/2018
• 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