MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH TI USS LOW PROFILE FRACTURE CLAMP; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Catalog Number 498.831

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypersensitivity/Allergic reaction (1907); Skin Irritation (2076); Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

Patient gender and weight not available for reporting.Date reaction began is not known.Additional product codes: mni, mnh, kwp, kwq.Device was not explanted.Complainant part is not expected to be returned for manufacturer review/investigation.Facility address not available for reporting.Device is not distributed in the united states, but is similar to device marketed in the usa.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported patient was implanted with a 6.0mm titanium hard rod, a titanium universal spine system (uss) low profile fracture clamp, and a 6.2mm titanium schanz screw with dual core on (b)(6) 2016 for a column fracture at t12.On unknown date patient presented with a skin reaction comparable with an allergy.Reaction was treated for almost a year with antihistamines but proved difficult to control.A biopsy was performed on unknown date, results are not known.Patient currently maintains slight skin lesions on the thighs and legs.This report is for one (1) titanium uss low profile fracture clamp.This is report 2 of 3 for (b)(4).

• Brand Name: TI USS LOW PROFILE FRACTURE CLAMP
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK MEZZOVICO (CH); via cavazz 5; mezzovico 6805 ; SZ 6805
• Manufacturer Contact: michael cote ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7814768
• MDR Text Key: 118200174
• Report Number: 8030965-2018-55964
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 07611819111981
• UDI-Public: (01)07611819111981
• Combination Product (y/n): N
• PMA/PMN Number: K082572
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 498.831
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR