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

Model Number 51-606-40-91

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Impaired Healing (2378); Patient Problem/Medical Problem (2688)

Event Date 06/01/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr report were filed for this event, please see associated report: mdr 9610905-2018-00098.

Event Description

It was reported the patient fell and the distractor disengaged from the bone.Device was removed and replaced.

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 failure root cause 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: DISTRACTION, EXTERNAL
• Type of Device: PIN
• 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: 7630374
• MDR Text Key: 112057716
• Report Number: 9610905-2018-00121
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 00888118107985
• UDI-Public: (01)00888118107985
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K994154
• 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
• Report Date: 06/01/2018

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: 51-606-40-91
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/05/2018
• Event Location: Hospital
• Date Report to Manufacturer: 06/01/2018
• Initial Date Manufacturer Received: 06/01/2018
• Initial Date FDA Received: 06/22/2018
• Supplement Dates Manufacturer Received: 12/05/2018
• Supplement Dates FDA Received: 12/07/2018
• 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
• Patient Age: 2 YR