MAUDE Adverse Event Report: KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG DISTRACTION; PIN

Model Number 51-606-50-91

Device Problems Use of Device Problem (1670); Loss of Osseointegration (2408)

Patient Problem Impaired Healing (2378)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Reference exemption number e2017029.Possible lot numbers 33281199 or 33286074.

Event Description

It was reported the distractor pin pulled from the bone.The pins were removed and replaced.

Manufacturer Narrative

An investigation was performed using a stereo microscope revealed tensile cracks.Further observation determined there were no indications of material or manufacturing defects.The complaint percentage was calculated, and it is determined that the complaint percentage falls within the design risk limits adhered to at klm.During the investigation the product lot number identified was reviewed in the device history records.The dhr review showed no discrepancies or anomalies.The investigation results conclude that the root cause for breakages were due to structural failure of the device due to mechanical overload.If further information is obtained that might add value to the contents of the investigation report, an additional follow-up report will be submitted.Manufraturing date: 33281199 13nov2018, 33286074 19nov2018.

• Brand Name: DISTRACTION
• Type of Device: PIN
• Manufacturer (Section D): KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG; kolbinger strasse 10; muehlheim/donau, 78570 ; GM 78570
• MDR Report Key: 9498391
• MDR Text Key: 185013054
• Report Number: 9610905-2019-00234
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 00888118107992
• UDI-Public: (01)00888118107992
• Combination Product (y/n): N
• PMA/PMN Number: K994154
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 51-606-50-91
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/10/2020
• Event Location: Hospital
• Date Report to Manufacturer: 12/05/2019
• Date Manufacturer Received: 06/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 66 YR