Complaint confirmed.One unpackaged ar-9145-48 uni glenoid-peripheral lock screw serial/batch number (b)(6) was received for investigation.Visual evaluation found that the returned device's hex geometry was damaged, maybe due to excessive tightening forces.The method of bone preparation employed during the procedure, as well as the bone quality encountered, was not provided.A cause for the reported failure may be a patient-specific event.Per dfu-0189-12 at revision 0.C.Contraindications.3.Foreign body sensitivity.Where material sensitivity is suspected, appropriate tests should be made, and sensitivity ruled out prior to implantation.4.Any active infection or blood supply limitations.D.Adverse effects.1.Infections, both deep and superficial.2.Foreign body reactions.7.Allergies and other reactions to device materials.
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